Ventilator Management Protocols Research Articles

Design and rationale of the CHILL phase II trial of hypothermia and neuromuscular blockade for acute respiratory distress syndrome

The Cooling to Help Injured Lungs (CHILL) trial is an open label, two group, parallel design multicenter, randomized phase IIB clinical trial assessing the efficacy and safety of targeted temperature management with combined external cooling and neuromuscular blockade to block shivering in patients with early moderate-severe acute respiratory distress syndrome (ARDS). This report provides the background and rationale for the clinical trial and outlines the methods using the Consolidated Standards of Reporting Trials guidelines. Key design challenges include: [1] protocolizing important co-interventions; [2] incorporation of patients with COVID-19 as the cause of ARDS; [3] inability to blind the investigators; and [4] ability to obtain timely informed consent from patients or legally authorized representatives early in the disease process. Results of the Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) trial informed the decision to mandate sedation and neuromuscular blockade only in the group assigned to therapeutic hypothermia and proceed without this mandate in the control group assigned to a usual temperature management protocol. Previous trials conducted in National Heart, Lung, and Blood Institute ARDS Clinical Trials (ARDSNet) and Prevention and Early Treatment of Acute Lung Injury (PETAL) Networks informed ventilator management, ventilation liberation and fluid management protocols. Since ARDS due to COVID-19 is a common cause of ARDS during pandemic surges and shares many features with ARDS from other causes, patients with ARDS due to COVID-19 are included. Finally, a stepwise approach to obtaining informed consent prior to documenting critical hypoxemia was adopted to facilitate enrollment and reduce the number of candidates excluded because eligibility time window expiration.

New York City Innocence Lost: Cardiology in the COVID-19 Pandemic.

New York City Innocence Lost: Cardiology in the COVID-19 Pandemic.

Potential Acceptability of a Pediatric Ventilator Management Computer Protocol.

To examine issues regarding the granularity (size/scale) and potential acceptability of recommendations in a ventilator management protocol for children with pediatric acute respiratory distress syndrome. Survey/questionnaire. The eight PICUs in the Collaborative Pediatric Critical Care Research Network. One hundred twenty-two physicians (attendings and fellows). None. We used an online questionnaire to examine attitudes and assessed recommendations with 50 clinical scenarios. Overall 80% of scenario recommendations were accepted. Acceptance did not vary by provider characteristics but did vary by ventilator mode (high-frequency oscillatory ventilation 83%, pressure-regulated volume control 82%, pressure control 75%; p = 0.002) and variable adjusted (ranging from 88% for peak inspiratory pressure and 86% for FIO2 changes to 69% for positive end-expiratory pressure changes). Acceptance did not vary based on child size/age. There was a preference for smaller positive end-expiratory pressure changes but no clear granularity preference for other variables. Although overall acceptance rate for scenarios was good, there was little consensus regarding the size/scale of ventilator setting changes for children with pediatric acute respiratory distress syndrome. An acceptable protocol could support robust evaluation of ventilator management strategies. Further studies are needed to determine if adherence to an explicit protocol leads to better outcomes.

Ventilator management protocols in pediatrics.

Management of mechanical ventilation is a complex process with outcomes affected by multiple patient and caregiver variable. Well-constructed protocols represent the synthesis of best available evidence regarding ventilator management. In adults, protocols improve important outcomes such as duration of mechanical ventilation, length of stay, and complication rates; however, protocols are not uniformly successful. In pediatrics, the available evidence does not suggest that ventilator management protocols should be adopted routinely, which may be due to pediatric-specific attributes such as a generally shorter weaning duration. Evidence suggests support for protocols to carefully titrate sedation. In addition, daily assessment of SBTs improves patient outcomes and should be more uniformly adopted in pediatrics. Ventilator-related outcomes may be affected by other confounding factors such as nutrition and fluid balance. Specific subpopulations, such as children who have congenital heart disease, may present opportunities for focused use of ventilator management protocols. Protocolized ventilation has an important place in trials of new therapeutic strategies such as surfactant or proning. It is hoped that future research will further define the appropriate use of protocols in the general PICU population. Although specific protocols cannot be routinely recommended, a multidisciplinary team approach to synthesizing available literature and determining best practice is a useful model. This approach will foster "team ownership" of ventilator management by all involved, thus engendering the best possible outcomes for critically ill children who require mechanical ventilation.

Protocols and Hospital Mortality in Critically Ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study.

Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized ICUs have superior patient outcomes compared with less highly protocolized ICUs. Observational study in which participating ICUs completed a general assessment and enrolled new patients 1 day each week. A total of 6,179 critically ill patients. Fifty-nine ICUs in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study. None. The primary exposure was the number of ICU protocols; the primary outcome was hospital mortality. A total of 5,809 participants were followed prospectively, and 5,454 patients in 57 ICUs had complete outcome data. The median number of protocols per ICU was 19 (interquartile range, 15-21.5). In single-variable analyses, there were no differences in ICU and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in ICUs with a high versus low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p = 0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between ICUs with high versus low numbers of protocols for lung protective ventilation in acute respiratory distress syndrome (47% vs 52%; p = 0.28) and for spontaneous breathing trials (55% vs 51%; p = 0.27). Clinical protocols are highly prevalent in U.S. ICUs. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality.

Tele-ICU Partners Enhance Evidence-Based Practice

Evidence-based practice (EBP) has become more than just a trendy buzzword in health care; EBP validates care delivery methods and grants satisfaction to nurses in knowing the care they provide is based on valid, current information. Research-based enhancements are paramount to the advancement of nursing practice and prompt the implementation of creative methods to improve care. The advent of the tele–intensive care unit (ICU) introduces new members of the health care team to assist with implementation of EBP initiatives. This new partnership results in improved length of stay, mortality rates, and ventilator times for critical care patients. Current literature suggests that a clinician-driven, standardized ventilator management protocol is of significant benefit. Tele-ICU clinicians provide an interactive element to coordinate interdisciplinary team efforts. Enhanced communication, data evaluation, and timely intervention expedite the weaning process and reduce ventilator length of stay. Consistent collaboration between tele-ICU and bedside clinicians successfully improves patient outcomes through standardized adherence to best-practice initiatives.

Tele-ICU Partners Enhance Evidence-Based Practice

Evidence-based practice (EBP) has become more than just a trendy buzzword in health care; EBP validates care delivery methods and grants satisfaction to nurses in knowing the care they provide is based on valid, current information. Research-based enhancements are paramount to the advancement of nursing practice and prompt the implementation of creative methods to improve care. The advent of the tele-intensive care unit (ICU) introduces new members of the health care team to assist with implementation of EBP initiatives. This new partnership results in improved length of stay, mortality rates, and ventilator times for critical care patients. Current literature suggests that a clinician-driven, standardized ventilator management protocol is of significant benefit. Tele-ICU clinicians provide an interactive element to coordinate interdisciplinary team efforts. Enhanced communication, data evaluation, and timely intervention expedite the weaning process and reduce ventilator length of stay. Consistent collaboration between tele-ICU and bedside clinicians successfully improves patient outcomes through standardized adherence to best-practice initiatives.

The Mechanical Ventilator: Past, Present, and Future

The use of ventilatory assistance can be traced back to biblical times. However, mechanical ventilators, in the form of negative-pressure ventilation, first appeared in the early 1800s. Positive-pressure devices started to become available around 1900 and today's typical intensive care unit (ICU) ventilator did not begin to be developed until the 1940s. From the original 1940s ventilators until today, 4 distinct generations of ICU ventilators have existed, each with features different from that of the previous generation. All of the advancements in ICU ventilator design over these generations provide the basis for speculation on the future. ICU ventilators of the future will be able to integrate electronically with other bedside technology; they will be able to effectively ventilate all patients in all settings, invasively and noninvasively; ventilator management protocols will be incorporated into the basic operation of the ventilator; organized information will be presented instead of rows of unrelated data; alarm systems will be smart; closed-loop control will be present on most aspects of ventilatory support; and decision support will be available. The key term that will be used to identify these future ventilators will be smart!

Síndrome de Distrés Respiratorio Agudo, durante la pandemia de Influenza A H1N1 2009 en Ecuador

Objective Among the most severe complications caused by the influenza A virus H1N1 pandemic is the Acute Respiratory Distress Syndrome (ARDS). The main objective of this study was to assess mortality after applying a strict protocol of ventilatory management and to describe the clinical characteristics of the patients. Design A prospective cohort study. Setting Intensive care unit (ICU) of the Hospital Enrique Garcés of the City of Quito. Patients Patients admitted to the ICU with a diagnosis of severe pneumonia, ARDS, and high suspicion of influenza A H1N1. Primary variables of interest Demographic variables, severity, diagnostic scores of community-acquired pneumonia, ventilator management protocol and mortality at 28 days, as principal effect of the study, were collected. Results 24 patients were studied, 100% with a diagnosis of ARDS, mean age 41.1 (±14.8). Severe viral pneumonia predominated in these patients, mean APACHE was 18, average PaO 2/FiO 2 on admission was 74.9, 100% had multisystemic involvement. A total of 91.3% received oseltamivir 150 mg w/12 h for 14 days, the mean time between onset of symptoms and antiviral administration was 6.74 days. Intra-ICU mortality was 16.6%, and 28 days was 16.6%. Conclusions After applying a strict management protocol for ventilatory management, mortality in this patient group was 16.6. We also stress that obesity and early renal failure were independent risk factors for mortality.

Assessing Data Quality in Manual Entry of Ventilator Settings

ObjectiveTo evaluate the data quality of ventilator settings recorded by respiratory therapists using a computer charting application and assess the impact of incorrect data on computerized ventilator management protocols. DesignAn analysis of 29,054 charting events gathered over 12 months from 678 ventilated patients (1,736 ventilator days) in four intensive care units at a tertiary care hospital. MeasurementsTen ventilator settings were examined, including fraction of inspired oxygen (Fio2), positive end-expiratory pressure (PEEP), tidal volume, respiratory rate, peak inspiratory flow, and pressure support. Respiratory therapists entered values for each setting approximately every two hours using a computer charting application. Manually entered values were compared with data acquired automatically from ventilators using an implementation of the ISO/IEEE 11073 Medical Information Bus (MIB). Data quality was assessed by measuring the percentage of time that the two sources matched. Charting delay, defined as the interval between data observation and data entry, also was measured. ResultsThe percentage of time that settings matched ranged from 99.0% (PEEP) to 75.9% (low tidal volume alarm setting). The average charting delay for each charting event was 6.1 minutes, including an average of 1.8 minutes spent entering data in the charting application. In 559 (3.9%) of 14,263 suggestions generated by computerized ventilator management protocols, one or more manually charted setting values did not match the MIB data. ConclusionEven at institutions where manual charting of ventilator settings is performed well, automatic data collection can eliminate delays, improve charting efficiency, and reduce errors caused by incorrect data.

Adaptive support ventilation.

Adaptive support ventilation (ASV) is a newer form of closed-loop ventilation control available on the Galileo ventilator (Hamilton Medical). ASV provides automated selection of initial ventilator parameters based on measurements of patient lung mechanics and breathing effort. After initiation, ASV will "titrate" ventilator output (mandatory breath rate, tidal volume, inspiratory pressure, inspiratory time, and I to E ratio) to maintain a calculated optimal breathing pattern that ensures delivery of a clinician selected minute ventilation target. ASV may be thought of as an "electronic" ventilator management protocol that may improve the safety and efficacy of mechanical ventilation. Additional clinical investigations regarding the effect of ASV on outcome, ventilator days, and so forth are forthcoming.

Percutaneous extracorporeal arteriovenous carbon dioxide removal improves survival in respiratory distress syndrome: A prospective randomized outcomes study in adult sheep

Objective: Arteriovenous carbon dioxide removal (AVCO2R) uses a simple arteriovenous shunt for CO2 removal to minimize barotrauma/volutrauma from mechanical ventilation. We performed a prospective randomized outcomes study of AVCO2R in our new, clinically relevant model of respiratory distress syndrome. Methods: Adult sheep (n = 18) received an LD50 severe smoke inhalation and 40% third-degree burn. When respiratory distress syndrome developed (PaO2/FIO2 < 200 at 40 to 48 hours), animals were randomized to the AVCO2R (n = 9) or sham group (n = 9) for 7 days. Ventilator management protocols mandated reductions in minute ventilation, first tidal volume to peak inspiratory pressure less than 30 cm H2O, then respiratory rate when PaCO2 was less than 40 mm Hg. PaO2 was kept above 60 mm Hg by adjusting FIO2. When FIO2 was 0.21, animals were weaned. Results: The study required 2946 animal-hours of critical care with 696 AVCO2R hours. One died in each group during model development. AVCO2R flow from 820 mL/min to 970 mL/min (11% to 14% cardiac output) removed CO2 at a rate of 92 to 116 mL/min (mean 103 mL/min; 93%-97% of CO2 production). Heart rate, mean arterial pressure, cardiac output, and pulmonary arterial wedge pressure remained relatively constant. Within 48 hours, AVCO2R allowed significant ventilator reductions versus baseline in the following measurements: tidal volume (420 to 270 mL), peak inspiratory pressure (25 to 14 cm H2O), minute ventilation (13 to 5 L/min), respiratory rate (26 to 16 breaths/min), and FIO2 (0.88 to 0.35). Ventilator-free days with AVCO2R were 3.9 versus 0.2 (P <.01) for sham animals, and ventilator-dependent days with AVCO2R were 2.4 versus 6.2 (P <.01) for the 3 sham survivors. All 8 AVCO2R animals and 3 of 8 sham animals survived 7 days after randomization. Conclusions: Percutaneous AVCO2R achieved significant reduction in airway pressures, increased ventilator-free days, decreased ventilator-dependent days, and improved survival in a sheep model of respiratory distress syndrome. (J Thorac Cardiovasc Surg 2001;121:542-51)

Protocol Weaning of Mechanical Ventilation in Medical and Surgical Patients by RespiratoryCare Practitioners and Nurses: Effect on Weaning Time and Incidence of Ventilator-Associated Pneumonia

(1) To determine the effect of a single ventilator management protocol (VMP) used in medical and surgical ICUs on the duration of mechanical ventilation. (2) To determine the effect of a VMP on the incidence of ventilator-associated pneumonia (VAP). Prospective, randomized, controlled study. : University medical center. Three hundred eighty-five patients receiving mechanical ventilation between June 1997 and May 1998. A respiratory care practitioner- and registered nurse-driven VMP. Intervention and control groups were comparable with respect to age, sex, severity of illness and injury, and duration of respiratory failure at the time of randomization. The duration of mechanical ventilation for patients was decreased from a median of 124 h for the control group to 68 h in the VMP group (p = 0.0001). Thirty-one total instances of VAP were noted. Twelve patients in the surgical control group had VAP, compared with 5 in the surgical VMP group (p = 0.061). The impact of the VMP on VAP frequency was less for medical patients. Mortality and ventilator discontinuation failure rates were similar between control and VMP groups. A VMP designed for multidisciplinary use was effective in reducing duration of mechanical ventilatory support without any adverse effects on patient outcome. The VMP was also associated with a decrease in incidence of VAP in trauma patients. These results, in conjunction with prior studies, suggest that VMPs are highly effective means of improving care, even in university ICUs.

Total Arteriovenous CO 2 Removal: Simplifying Extracorporeal Support for Respiratory Failure

Background. To reduce the complexity, complications, and cost of conventional extracorporeal membrane oxygenation, we have developed a technique of simplified arteriovenous extracorporeal CO 2 removal (AVCO 2R) with a low-resistance membrane gas exchanger for total CO 2 removal to provide lung rest in the setting of severe respiratory failure. Methods. We initially used AVCO 2R in healthy animals to quantify the gas exchange capabilities of the system and establish ventilator management protocols for the subsequent studies of AVCO 2R in a large animal model of respiratory failure secondary to a severe smoke inhalation injury. Results. In healthy sheep the maximum spontaneous arteriovenous flow ranged from 1,350 to 1,500 mL/min, whereas CO 2 removal plateaued at a blood flow of approximately 1,000 mL/min in which 112 ± 3 mL/min CO 2 was removed, allowing an 84% reduction in the minute ventilation of from 6.9 ± 0.8 L/min to 1.1 ± 0.4 L/min ( p < 0.01) without triggering hypercapnia. A subsequent reduction in extracorporeal flow at a reduced minute volume led to the development of hypercapnia only if it decreased to less than 500 mL/min. We also applied AVCO 2R in mechanically ventilated sheep with a severe smoke inhalation injury and removed 95% (111 ± 4 mL/min) of the total CO 2 production. This allowed the minute ventilation to be reduced by 95% and the peak inspiratory pressures by 52% (both p < 0.05) over 6 hours and produced no adverse hemodynamic effects. The partial pressure of arterial oxygen was maintained above 100 mm Hg at a maximally reduced minute volume. The mean AVCO 2R flow was 1,213 ± 29 mL/min, averaging 27% ± 1% of the cardiac output. Conclusions. We conclude that AVCO 2R in a simple arteriovenous shunt is a less complicated technique than extracorporeal membrane oxygenation and is capable of total CO 2 removal that allows a significant reduction in the minute ventilation and peak airway pressure during severe respiratory failure.

Ventilator Management in Duchenne Muscular Dystrophy and Postpoliomyelitis Syndrome: Twelve Years’ Experience

The ventilator management protocol followed over the last 12 years in 23 patients with Duchenne muscular dystrophy (DMD) and six polio survivors with chronic respiratory failure (CRF) secondary to the late effects of poliomyelitis or postpolio syndrome (PPS) is reviewed. After the onset of respiratory failure, patients with DMD continued to show a classic course of progressive, generalized muscle weakness and a steadily declining vital capacity from an average of 482mL to 336mL. The DMD group required an average increase of 0.95 hours in their daily use of assisted ventilation per year. Their overall average length of survival was increased from 19 years 9 months to 25 years 9 months. Members of the postpolio group, to date, have shown no significant decrease in muscle strength nor have they needed more than nocturnal ventilation. Recommended evaluation and pulmonary follow-up for patients with CRF secondary to neuromuscular disease is outlined. Most of these patients can be managed for a number of years with body ventilators before a tracheotomy is necessary.