Helmet Noninvasive Ventilation Research Articles

Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial

BackgroundLong-term outcomes of patients treated with helmet noninvasive ventilation (NIV) are unknown: safety concerns regarding the risk of patient self-inflicted lung injury and delayed intubation exist when NIV is applied in hypoxemic patients. We assessed the 6-month outcome of patients who received helmet NIV or high-flow nasal oxygen for COVID-19 hypoxemic respiratory failure.MethodsIn this prespecified analysis of a randomized trial of helmet NIV versus high-flow nasal oxygen (HENIVOT), clinical status, physical performance (6-min-walking-test and 30-s chair stand test), respiratory function and quality of life (EuroQoL five dimensions five levels questionnaire, EuroQoL VAS, SF36 and Post-Traumatic Stress Disorder Checklist for the DSM) were evaluated 6 months after the enrollment.ResultsAmong 80 patients who were alive, 71 (89%) completed the follow-up: 35 had received helmet NIV, 36 high-flow oxygen. There was no inter-group difference in any item concerning vital signs (N = 4), physical performance (N = 18), respiratory function (N = 27), quality of life (N = 21) and laboratory tests (N = 15). Arthralgia was significantly lower in the helmet group (16% vs. 55%, p = 0.002). Fifty-two percent of patients in helmet group vs. 63% of patients in high-flow group had diffusing capacity of the lungs for carbon monoxide < 80% of predicted (p = 0.44); 13% vs. 22% had forced vital capacity < 80% of predicted (p = 0.51). Both groups reported similar degree of pain (p = 0.81) and anxiety (p = 0.81) at the EQ-5D-5L test; the EQ-VAS score was similar in the two groups (p = 0.27). Compared to patients who successfully avoided invasive mechanical ventilation (54/71, 76%), intubated patients (17/71, 24%) had significantly worse pulmonary function (median diffusing capacity of the lungs for carbon monoxide 66% [Interquartile range: 47–77] of predicted vs. 80% [71–88], p = 0.005) and decreased quality of life (EQ-VAS: 70 [53–70] vs. 80 [70–83], p = 0.01).ConclusionsIn patients with COVID-19 hypoxemic respiratory failure, treatment with helmet NIV or high-flow oxygen yielded similar quality of life and functional outcome at 6 months. The need for invasive mechanical ventilation was associated with worse outcomes. These data indicate that helmet NIV, as applied in the HENIVOT trial, can be safely used in hypoxemic patients.Trial registration Registered on clinicaltrials.gov NCT04502576 on August 6, 2020

Introducing helmet non-invasive ventilation during COVID-19 pandemic: Early experience of two centres.

The helmet is a novel interface for delivering non-invasive ventilation (NIV). We conducted a case series to characterize introduction of the helmet interface in both COVID and non-COVID patients at two-centres. We enrolled all patients with respiratory failure admitted to the Juravinski Hospital (Hamilton, Canada) and St. Joseph's Health Center (Syracuse, New York) between November 1, 2020 and June 30, 2021 who used the helmet interface (Intersurgical StarMed) as part of this introduction into clinical practice. We collected patient demographics, reason for respiratory failure, NIV settings, device-related complications and outcomes. We report respiratory therapist's initial experiences with the helmet using descriptive results. We included 16 patients with a mean age of 64.3 ± 10.9 years. The most common etiology for respiratory failure was pneumonia (81.3%). The median duration of NIV during the ICU admission was 67.5 (15.3, 80.8) hours, with a mean maximum PS of 13.9 ± 6.6 cm H2O and a mean maximum PEEP of 10.4 ± 5.1 cm H20. Three patients (18.7%) did not tolerate the helmet. Ten (62.5%) patients ultimately required intubation, and 7 (43.4%) patients died while in the ICU. The most common reason for intubation was worsening hypoxia (70%). No adverse events related to the helmet were recorded. Over the 8-month period of this study, we found that the helmet was well tolerated in over 80% of patients, although, more than half ultimately required intubation. Randomized controlled trials with this device are required to fully assess the efficacy of this interface.

Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19

Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited. To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. This was a multicenter, pragmatic, randomized clinical trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021. Patients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen. The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation, barotrauma, skin pressure injury, and serious adverse events. Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, -8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, -3.1% [95% CI, -14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points. Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group. Results of this study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm. ClinicalTrials.gov Identifier: NCT04477668.

Helmet-Noninvasive Ventilation for Hospitalized Critically Ill COVID-19 Patients: Has Vaccination and the New Variants Changed Evidence?

Noninvasive ventilation (NIV) is a technique for breathing support that significantly improves gas exchange and vital signs, reducing intubation and mortality rates. Helmets, unlike facemasks, allow for longer-term treatment and better ventilation, also being more cost-effective. As of today, we have found no reviews addressing this topic. This review aims to identify, map, and describe the characteristics of the use of noninvasive ventilation through helmet interface in critically ill COVID-19 adult patients hospitalized in acute care settings throughout the multiple moments that defined the COVID-19 pandemic. This scoping review will follow the methodology for scoping reviews proposed by JBI. A set of relevant electronic databases will be searched using terms such as COVID-19, helmet, and noninvasive ventilation. Two reviewers will independently perform the study selection regarding their eligibility. Data extraction will be accomplished using a researcher’s developed tool considering the review questions. Findings will be presented in tables and a narrative description that aligns with the review’s objective. This scoping review will consider any quantitative, qualitative, mixed-methods studies and systematic review designs for inclusion, focusing on the use of helmet on critically ill adult patients with COVID-19 hospitalized in acute care settings.

Helmet NIV in Acute Hypoxemic Respiratory Failure due to COVID-19: Change in PaO2/FiO2 Ratio a Predictor of Success.

In acute respiratory failure due to severe coronavirus disease 2019 (COVID-19) pneumonia, mechanical ventilation remains challenging and may result in high mortality. The use of noninvasive ventilation (NIV) may delay required invasive ventilation, increase adverse outcomes, and have a potential aerosol risk to caregivers. Data of 30 patients were collected from patient files and analyzed. Twenty-one (70%) patients were weaned successfully after helmet-NIV support (NIV success group), and invasive mechanical ventilation was required in 9 (30%) patients (NIV failure group) of which 8 (26.7%) patients died. In NIV success vs failure patients, the mean baseline PaO2/FiO2 ratio (PFR) (147.2 ± 57.9 vs 156.8 ± 59.0 mm Hg; p = 0.683) and PFR before initiation of helmet (132.3 ± 46.9 vs 121.6 ± 32.7 mm Hg; p = 0.541) were comparable. The NIV success group demonstrated a progressive improvement in PFR in comparison with the failure group at 2 hours (158.8 ± 56.1 vs 118.7 ± 40.7 mm Hg; p = 0.063) and 24 hours (PFR-24) (204.4 ± 94.3 vs 121.3 ± 32.6; p = 0.016). As predictor variables, PFR-24 and change (delta) in PFR at 24 hours from baseline or helmet initiation (dPFR-24) were significantly associated with NIV success in univariate analysis but similar significance could not be reflected in multivariate analysis perhaps due to a small sample size of the study. The PFR-24 cutoff of 161 mm Hg and dPFR-24 cutoff of −1.44 mm Hg discriminate NIV success and failure groups with the area under curve (confidence interval) of 0.78 (0.62–0.95); p = 0.015 and 0.74 (0.55–0.93); p = 0.039, respectively. Helmet interface NIV may be a safe and effective tool for the management of patients with severe COVID-19 pneumonia with acute respiratory failure. More studies are needed to further evaluate the role of helmet NIV especially in patients with initial PFR <150 mm Hg to define PFR/dPFR cutoff at the earliest time point for prediction of helmet-NIV success.How to cite this article Jha OK, Kumar S, Mehra S, Sircar M, Gupta R. Helmet NIV in Acute Hypoxemic Respiratory Failure due to COVID-19: Change in PaO2/FiO2 Ratio a Predictor of Success. Indian J Crit Care Med 2021;25(10):1137–1146.

Inexpensive Multipatient Respiratory Monitoring System for Helmet Ventilation During COVID-19 Pandemic

Abstract Helmet continuous positive applied pressure is a form of noninvasive ventilation (NIV) that has been used to provide respiratory support to COVID-19 patients. Helmet NIV is low-cost, readily available, provides viral filters between the patient and clinician, and may reduce the need for invasive ventilation. Its widespread adoption has been limited, however, by the lack of a respiratory monitoring system needed to address known safety vulnerabilities and to monitor patients. To address these safety and clinical needs, we developed an inexpensive respiratory monitoring system based on readily available components suitable for local manufacture. Open-source design and manufacturing documents are provided. The monitoring system comprises flow, pressure, and CO2 sensors on the expiratory path of the helmet circuit and a central remote station to monitor up to 20 patients. The system is validated in bench tests, in human-subject tests on healthy volunteers, and in experiments that compare respiratory features obtained at the expiratory path to simultaneous ground-truth measurements from proximal sensors. Measurements of flow and pressure at the expiratory path are shown to deviate at high flow rates, and the tidal volumes reported via the expiratory path are systematically underestimated. Helmet monitoring systems exhibit high-flow rate, nonlinear effects from flow and helmet dynamics. These deviations are found to be within a reasonable margin and should, in principle, allow for calibration, correction, and deployment of clinically accurate derived quantities.

Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial

BackgroundNoninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation has multiple advantages over other oxygen support modalities but data about effectiveness are limited.MethodsIn this multicenter randomized trial of helmet noninvasive ventilation for COVID-19 patients, 320 adult ICU patients (aged ≥14 years or as per local standards) with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate of 10 L/min or higher) will be randomized to helmet noninvasive ventilation with usual care or usual care alone, which may include mask noninvasive ventilation, high-flow nasal oxygen, or standard oxygen therapy. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction in 28-day mortality from 40 to 25%. The primary outcome will be compared between the helmet and usual care group in the intention-to-treat using the chi-square test. Results will be reported as relative risk and 95% confidence interval. The first patient was enrolled on February 8, 2021. As of August 1, 2021, 252 patients have been enrolled from 7 centers in Saudi Arabia and Kuwait.DiscussionWe developed a detailed statistical analysis plan to guide the analysis of the Helmet-COVID trial, which is expected to conclude enrollment in November 2021.Trial registrationClinicalTrials.govNCT04477668. Registered on July 20, 2020

Helmet Non-invasive Ventilation Therapy: Measurement of comfort behaviour

Comfort is integral towards tolerance in helmet non-invasive ventilation (NIV) therapy among acute respiratory failure (ARF) patients. This study aims to measure the patients’ comfort behaviour level after completion of helmet NIV therapy. It is a quantitative, descriptive, observational study involving 67 ARF patients. Kolcaba's Comfort Behavioural Checklist (CBC) was used, with the highest score of 120. The mean CBC score was 88.54, SD 7.35, indicating moderate comfort level; for Acute Pulmonary Oedema (APO) and non- APO, patients were 89.88, SD 7.25, and 87.08, SD 7.80 respectively. This reflects genuine patients' response towards therapy which is significant for future improvement. Keywords: Helmet Continuous Positive Airway Pressure; CPAP; Kolcaba’s Behavioural Checklist; Acute Respiratory Failure eISSN: 2398-4287© 2021. The Authors. Published for AMER ABRA cE-Bs by e-International Publishing House, Ltd., UK. This is an open access article under the CC BYNC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Peer–review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians/Africans/Arabians) and cE-Bs (Centre for Environment-Behaviour Studies), Faculty of Architecture, Planning &amp; Surveying, Universiti Teknologi MARA, Malaysia. DOI: https://doi.org/10.21834/ebpj.v6i18.3082

Gas conditioning during helmet noninvasive ventilation: effect on comfort, gas exchange, inspiratory effort, transpulmonary pressure and patient\u2013ventilator interaction

BackgroundThere is growing interest towards the use of helmet noninvasive ventilation (NIV) for the management of acute hypoxemic respiratory failure. Gas conditioning through heat and moisture exchangers (HME) or heated humidifiers (HHs) is needed during facemask NIV to provide a minimum level of humidity in the inspired gas (15 mg H2O/L). The optimal gas conditioning strategy during helmet NIV remains to be established.MethodsTwenty patients with acute hypoxemic respiratory failure (PaO2/FiO2 < 300 mmHg) underwent consecutive 1-h periods of helmet NIV (PEEP 12 cmH2O, pressure support 12 cmH2O) with four humidification settings, applied in a random order: double-tube circuit with HHs and temperature set at 34 °C (HH34) and 37 °C (HH37); Y-piece circuit with HME; double-tube circuit with no humidification (NoH). Temperature and humidity of inhaled gas were measured through a capacitive hygrometer. Arterial blood gases, discomfort and dyspnea through visual analog scales (VAS), esophageal pressure swings (ΔPES) and simplified pressure–time product (PTPES), dynamic transpulmonary driving pressure (ΔPL) and asynchrony index were measured in each step.ResultsMedian [IqR] absolute humidity, temperature and VAS discomfort were significantly lower during NoH vs. HME, HH34 and HH37: absolute humidity (mgH2O/L) 16 [12–19] vs. 28 [23–31] vs. 28 [24–31] vs. 33 [29–38], p < 0.001; temperature (°C) 29 [28–30] vs. 30 [29–31] vs. 31 [29–32] vs 32. [31–33], p < 0.001; VAS discomfort 4 [2–6] vs. 6 [2–7] vs. 7 [4–8] vs. 8 [4–10], p = 0.03. VAS discomfort increased with higher absolute humidity (p < 0.01) and temperature (p = 0.007). Higher VAS discomfort was associated with increased VAS dyspnea (p = 0.001). Arterial blood gases, respiratory rate, ΔPES, PTPES and ΔPL were similar in all conditions. Overall asynchrony index was similar in all steps, but autotriggering rate was lower during NoH and HME (p = 0.03).ConclusionsDuring 1-h sessions of helmet NIV in patients with hypoxemic respiratory failure, a double-tube circuit with no humidification allowed adequate conditioning of inspired gas, optimized comfort and improved patient–ventilator interaction. Use of HHs or HME in this setting resulted in increased discomfort due to excessive heat and humidity in the interface, which was associated with more intense dyspnea.Trail Registration Registered on clinicaltrials.gov (NCT02875379) on August 23rd, 2016.

The "Dolphin" Prone Position in Awake COVID-19 Patients.

The "Dolphin" Prone Position in Awake COVID-19 Patients.

Noninvasive respiratory support for acute respiratory failure due to COVID-19.

Purpose of reviewNoninvasive respiratory support has been widely applied during the COVID-19 pandemic. We provide a narrative review on the benefits and possible harms of noninvasive respiratory support for COVID-19 respiratory failure.Recent findingsMaintenance of spontaneous breathing by means of noninvasive respiratory support in hypoxemic patients with vigorous spontaneous effort carries the risk of patient self-induced lung injury: the benefit of averting intubation in successful patients should be balanced with the harms of a worse outcome in patients who are intubated after failing a trial of noninvasive support.The risk of noninvasive treatment failure is greater in patients with the most severe oxygenation impairment (PaO2/FiO2 < 200 mmHg).High-flow nasal oxygen (HFNO) is the most widely applied intervention in COVID-19 patients with hypoxemic respiratory failure. Also, noninvasive ventilation (NIV) and continuous positive airway pressure delivered with different interfaces have been used with variable success rates. A single randomized trial showed lower need for intubation in patients receiving helmet NIV with specific settings, compared to HFNO alone.Prone positioning is recommended for moderate-to-severe acute respiratory distress syndrome patients on invasive ventilation. Awake prone position has been frequently applied in COVID-19 patients: one randomized trial showed improved oxygenation and lower intubation rate in patients receiving 6-h sessions of awake prone positioning, as compared to conventional management.SummaryNoninvasive respiratory support and awake prone position are tools possibly capable of averting endotracheal intubation in COVID-19 patients; carefully monitoring during any treatment is warranted to avoid delays in endotracheal intubation, especially in patients with PaO2/FiO2 < 200 mmHg.

Helmet noninvasive ventilation compared to facemask noninvasive ventilation and high-flow nasal cannula in acute respiratory failure: a systematic review and meta-analysis.

Although small randomised controlled trials (RCTs) and observational studies have examined helmet noninvasive ventilation (NIV), uncertainty remains regarding its role. We conducted a systematic review and meta-analysis to examine the effect of helmet NIV compared to facemask NIV or high-flow nasal cannula (HFNC) in acute respiratory failure. We searched multiple databases to identify RCTs and observational studies reporting on at least one of mortality, intubation, intensive care unit (ICU) length of stay, NIV duration, complications or comfort with NIV therapy. We assessed study risk of bias using the Cochrane Risk of Bias 2 tool for RCTs and the Ottawa-Newcastle Scale for observational studies, and rated certainty of pooled evidence using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) framework. We separately pooled data from 16 RCTs (n=949) and eight observational studies (n=396). Compared to facemask NIV, based on low certainty of evidence, helmet NIV may reduce mortality (relative risk 0.56, 95% CI 0.33-0.95) and intubation (relative risk 0.35, 95% CI 0.22-0.56) in both hypoxic and hypercapnic respiratory failure, but may have no effect on duration of NIV. There was an uncertain effect of helmet NIV on ICU length of stay and development of pressure sores. Data from observational studies were consistent with the foregoing findings but of lower certainty. Based on low and very low certainty data, helmet NIV may reduce intubation compared to HFNC, but its effect on mortality is uncertain. Compared to facemask NIV, helmet NIV may reduce mortality and intubation; however, the effect of helmet NIV compared to HFNC remains uncertain.

Helmets Save Lives, or At Least Ventilator-Free Days: August 2021 Annals of Emergency Medicine Journal Club

Grieco DL, Menga LS, Cesarano M, et al. Effect of helmet noninvasive ventilation vs high-flow nasal oxygen on days free of respiratory support in patients with COVID-19 and moderate to severe hypoxemic respiratory failure: the HENIVOT randomized clinical trial. JAMA. 2021;325:1731-1743.

Non-invasive ventilatory support and high-flow nasal oxygen as first-line treatment of acute hypoxemic respiratory failure and ARDS.

The role of non-invasive respiratory support (high-flow nasal oxygen and noninvasive ventilation) in the management of acute hypoxemic respiratory failure and acute respiratory distress syndrome is debated. The oxygenation improvement coupled with lung and diaphragm protection produced by non-invasive support may help to avoid endotracheal intubation, which prevents the complications of sedation and invasive mechanical ventilation. However, spontaneous breathing in patients with lung injury carries the risk that vigorous inspiratory effort, combined or not with mechanical increases in inspiratory airway pressure, produces high transpulmonary pressure swings and local lung overstretch. This ultimately results in additional lung damage (patient self-inflicted lung injury), so that patients intubated after a trial of noninvasive support are burdened by increased mortality. Reducing inspiratory effort by high-flow nasal oxygen or delivery of sustained positive end-expiratory pressure through the helmet interface may reduce these risks. In this physiology-to-bedside review, we provide an updated overview about the role of noninvasive respiratory support strategies as early treatment of hypoxemic respiratory failure in the intensive care unit. Noninvasive strategies appear safe and effective in mild-to-moderate hypoxemia (PaO2/FiO2 > 150 mmHg), while they can yield delayed intubation with increased mortality in a significant proportion of moderate-to-severe (PaO2/FiO2 ≤ 150 mmHg) cases. High-flow nasal oxygen and helmet noninvasive ventilation represent the most promising techniques for first-line treatment of severe patients. However, no conclusive evidence allows to recommend a single approach over the others in case of moderate-to-severe hypoxemia. During any treatment, strict physiological monitoring remains of paramount importance to promptly detect the need for endotracheal intubation and not delay protective ventilation.

Cancer, transplant, and immunocompromising conditions were not significantly associated with severe illness or death in hospitalized COVID-19 patients.

ObjectivePatients with cancer, transplant, and other immunocompromising conditions are at uncertain risk of severe COVID-19 illness. This study aimed to clarify whether patients with immunocompromising conditions were more likely to develop severe COVID-19 illness in a single urban academic medical center.MethodsA retrospective chart review and electronic data extraction of the first 401 patients at the University of Chicago Hospitals with SARS-CoV-2 infection was performed. Patients met criteria for severe COVID-19 illness if they required ICU level care, high flow oxygen, positive pressure support, helmet non-invasive ventilation, mechanical ventilation, or ECMO, developed ARDS, or died.ResultsThe mean age was 60 years, 52% were women, 90% were African American, and mortality at 30 days post discharge was 13%. Severe COVID-19 illness was found in 168 (40%) patients. Of the 56 patients with past or current cancer, 25 (45%) had severe illness (p=0.76). Of the 55 patients with other immunocompromised conditions, 24 (44%) had severe illness (p=0.89) After controlling for age, sex, and race, neither cancer (p=0.73) nor immunocompromised conditions (p=0.64) were associated with severe illness.ConclusionNo association was found between severe COVID-19 illness and cancer, transplant, and other immunocompromising conditions in a cohort of mostly African American patients.

Non-invasive respiratory support strategies in COVID-19

Non-invasive respiratory support strategies in COVID-19

COVID-19 Coverage This Week in NEJM Journal Watch

Dear readers,This week, NEJM Journal Watch covered COVID-19–related topics including helmet noninvasive ventilation in the ICU, SARS-CoV-2 vaccination

Helmet Noninvasive Ventilation Helped Patients with COVID-19 Avoid Intubation

Patients with hypoxemic respiratory failure are treated with supplemental oxygen, often high flow, with progression to invasive ventilation if

Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure

High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19. To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone. Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200). Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55). The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay. Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, -2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, -21% [95% CI, -38% to -3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, -1% [95% CI, -17% to 15%]; P > .99). Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation. ClinicalTrials.gov Identifier: NCT04502576.

Use of Helmet-Based Noninvasive Ventilation in Air Medical Transport of Coronavirus Disease 2019 Patients

Helmet-based noninvasive ventilation (NIV) is a viable option for the safe transport of potential or known coronavirus disease 2019 patients. Given the most likely modes of transmission through droplets, aerosols, and fomite contact, airway procedures such as endotracheal intubation place air medical crews and other health care providers at high risk for exposure. This, together with data that suggest that a large cohort of coronavirus disease 2019 patients have better outcomes if we can avoid intubating them, creates a need for a safe method of NIV or high-flow oxygen delivery during transport. Commonly used and successful in-hospital regimens for these patients are high-flow nasal cannula and continuous positive airway pressure or bilevel positive airway pressure. In some studies, helmet NIV has been shown to be a viable, if not superior, alternative to these therapies for patients with acute hypoxemic respiratory failure. Furthermore, because it is a sealed and closed space that completely isolates the patient's airway and breathing, it provides a very high degree of protection from exposure to pathogens transmitted through droplets or aerosols. This article discusses practical implementation of helmet NIV in air medical transport.