High Oxygen Saturation Target Research Articles

Oxygen-Saturation Targets and Cognitive and Functional Outcomes in Mechanically Ventilated Adults.

Rationale: Among mechanically ventilated critically ill adults, the PILOT (Pragmatic Investigation of Optimal Oxygen Targets) trial demonstrated no difference in ventilator-free days among lower, intermediate, and higher oxygen-saturation targets. The effects on long-term cognition and related outcomes are unknown.Objectives: To compare the effects of lower (90% [range, 88-92%]), intermediate (94% [range, 92-96%]), and higher (98% [range, 96-100%]) oxygen-saturation targets on long-term outcomes.Methods: Twelve months after enrollment in the PILOT trial, blinded neuropsychological raters conducted assessments of cognition, disability, employment status, and quality of life. The primary outcome was global cognition as measured using the Telephone Montreal Cognitive Assessment. In a subset of patients, an expanded neuropsychological battery measured executive function, attention, immediate and delayed memory, verbal fluency, and abstraction.Measurements and Main Results: A total of 501 patients completed follow-up, including 142 in the lower, 186 in the intermediate, and 173 in the higher oxygen target groups. Median (interquartile range) peripheral oxygen saturation values in the lower, intermediate, and higher target groups were 94% (91-96%), 95% (93-97%), and 97% (95-99%), respectively. Telephone Montreal Cognitive Assessment score did not differ between lower and intermediate (adjusted odds ratio [OR], 1.36 [95% confidence interval (CI), 0.92-2.00]), intermediate and higher (adjusted OR, 0.90 [95% CI, 0.62-1.29]), or higher and lower (adjusted OR, 1.22 [95% CI, 0.83-1.79]) target groups. There was also no difference in individual cognitive domains, disability, employment, or quality of life.Conclusions: Among mechanically ventilated critically ill adults who completed follow-up at 12 months, oxygen-saturation targets were not associated with cognition or related outcomes.

Correlation of retinopathy of prematurity with oxygen saturation in preterm babies in a tertiary care center: A noble guide

To find the correlation of retinopathy of prematurity (ROP) with oxygen saturation among preterm babies in neonatal intensive care unit (NICU) of a tertiary care centre. This Prospective cross-sectional study was conducted on 64 premature neonates of gestational age < 36 weeks who were on oxygen and were admitted in NICU after obtaining ethical clearance. We compare the effect of two oxygenation strategies on development of ROP in two groups. Oxygen ranged from 86-90% in one group (32 neonates) and 91-94% in another group (32 neonates). Screening of all neonates were done by one examiner. The data were analyzed using Statistical Package for the Social Sciences (SPSS) version 26. For categorical data, Chi-square test was used. For continuous data, Mann Witney U test were used and p- value-<0.05 was taken as significant. Among 64 babies, 32 babies were on 86-90% of oxygen, 5 babies had disease and the remaining 32 babies who were on 91-94% of oxygen, 14 babies had developed disease showed a statistically significant relationship between ROP and oxygen saturation (p=0.014). High oxygen saturation target is one of the important risk factors leading to the development of ROP. Lower oxygen saturation reduced the prevalence as well as had no deleterious effect on general health of baby. Therefore, accurate measurement of oxygen concentration by probe and proper monitoring of SpO2 levels must be done in every NICU.

Visual impairment due to retinopathy of prematurity and concomitant disabilities in the Netherlands

AimDetermine incidence of visual impairment due to retinopathy of prematurity (ROP) and concomitant disabilities between 2009 and 2018 in the Netherlands and compare data to four former similar studies. Secondly, monitor if infants were missed for ROP-screening since the adoption of stricter, risk factor guided criteria (2013). MethodsRetrospective inventory on anonymous data of infants diagnosed with ROP from Dutch visual impairment-institutes. Data including: best corrected visual acuity, ROP-treatment and concomitant disabilities: bronchopulmonary dysplasia, behavioral abnormalities, epilepsy, hearing deficit, developmental delay, cerebral palsy and cerebral visual impairment. During the study period, lower age limit for neonatal life support (2010) and higher oxygen saturation targets (2014) were implemented. ResultsRecords of 53 infants were analyzed. Visual impairment incidence due to ROP was 2.02 per 100.000 live births (2000–2009: 1.84, p = 0.643). Compared to earlier periods (1975–2000), a significant decrease was observed. The incidence of concomitant disabilities remained stable. Mean gestational age (GA) continued to decrease to 26.6 ± 1.9 weeks (2000–2009: 27.4 ± 2.0 weeks, p = 0.047). All patients met the screening inclusion criteria. ConclusionThe incidence of visual impairment due to ROP and concomitant disabilities between 2009 and 2018 has not increased, despite lower GA and higher oxygen saturation targets. None of the infants were missed for ROP screening following introduction of more restricted screening inclusion criteria.

Effect of Lower vs Higher Oxygen Saturation Targets on Survival to Hospital Discharge Among Patients Resuscitated After Out-of-Hospital Cardiac Arrest

The administration of a high fraction of oxygen following return of spontaneous circulation in out-of-hospital cardiac arrest may increase reperfusion brain injury. To determine whether targeting a lower oxygen saturation in the early phase of postresuscitation care for out-of-hospital cardiac arrest improves survival at hospital discharge. This multicenter, parallel-group, randomized clinical trial included unconscious adults with return of spontaneous circulation and a peripheral oxygen saturation (Spo2) of at least 95% while receiving 100% oxygen. The trial was conducted in 2 emergency medical services and 15 hospitals in Victoria and South Australia, Australia, between December 11, 2017, and August 11, 2020, with data collection from ambulance and hospital medical records (final follow-up date, August 25, 2021). The trial enrolled 428 of a planned 1416 patients. Patients were randomized by paramedics to receive oxygen titration to achieve an oxygen saturation of either 90% to 94% (intervention; n = 216) or 98% to 100% (standard care; n = 212) until arrival in the intensive care unit. The primary outcome was survival to hospital discharge. There were 9 secondary outcomes collected, including hypoxic episodes (Spo2 <90%) and prespecified serious adverse events, which included hypoxia with rearrest. The trial was stopped early due to the COVID-19 pandemic. Of the 428 patients who were randomized, 425 were included in the primary analysis (median age, 65.5 years; 100 [23.5%] women) and all completed the trial. Overall, 82 of 214 patients (38.3%) in the intervention group survived to hospital discharge compared with 101 of 211 (47.9%) in the standard care group (difference, -9.6% [95% CI, -18.9% to -0.2%]; unadjusted odds ratio, 0.68 [95% CI, 0.46-1.00]; P = .05). Of the 9 prespecified secondary outcomes collected during hospital stay, 8 showed no significant difference. A hypoxic episode prior to intensive care was observed in 31.3% (n = 67) of participants in the intervention group and 16.1% (n = 34) in the standard care group (difference, 15.2% [95% CI, 7.2%-23.1%]; OR, 2.37 [95% CI, 1.49-3.79]; P < .001). Among patients achieving return of spontaneous circulation after out-of-hospital cardiac arrest, targeting an oxygen saturation of 90% to 94%, compared with 98% to 100%, until admission to the intensive care unit did not significantly improve survival to hospital discharge. Although the trial is limited by early termination due to the COVID-19 pandemic, the findings do not support use of an oxygen saturation target of 90% to 94% in the out-of-hospital setting after resuscitation from cardiac arrest. ClinicalTrials.gov Identifier: NCT03138005.

Survival rate dependent variations in retinopathy of prematurity treatment rates in very low birth weight infants

As increased oxidative stress causes increased mortality and morbidities like bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP) in very low birth weight infants (VLBWIs), the conundrum of improved survival but increased ROP observed with the high oxygen saturation target range of 91–95% is difficult to explain. To determine the survival rate-dependent variation in ROP treatment rate, 6292 surviving eligible VLBWIs registered in the Korean Neonatal Network were arbitrarily grouped according to the survival rate of infants at 23–24 weeks’ gestation as group I (> 70%, n = 1626), group II (40–70%, n = 2984) and group III (< 40%, n = 1682). Despite significantly higher survival and lower BPD rates in group I than in groups II and III, the ROP treatment rate was higher in group I than in groups II and III. However, the adjusted odds ratios for ROP treatment were not significantly different between the study groups, and the ROP treatment rate in the infants at 23–24 weeks’ gestation was 21-fold higher than the infants at ≥ 27 weeks’ gestation. The controversial association between improved survival and reduced BPD reflecting quality improvement of neonatal intensive care but increased ROP treatment rate might be primarily attributed to the improved survival of the most immature infants.

Strategies to Prevent Severe Retinopathy of Prematurity: A 2020 Update and Meta-analysis.

The incidence of retinopathy of prematurity (ROP) is showing an increasing trend in the United States. This may be because of increasing survival rates among extremely preterm infants (<25 weeks' gestation) and targeting higher oxygen saturation. Five randomized clinical trials of low versus high oxygen saturation target ranges found increased mortality in the low oxygen saturation target group and an increased incidence of ROP in the high oxygen saturation target group. The American Academy of Pediatrics recommends using an oxygen saturation target range of 90% to 95% in extremely low-birthweight infants. The change of practice to target this higher oxygen saturation range, from admission until discharge, may be contributing to the increasing incidence of ROP in extremely preterm infants. To decrease the incidence of ROP without increasing mortality, 2 new cohort trials suggest gradually increasing oxygen saturation targets as preterm infants mature. There is evidence that human milk, vitamin A, and omega-3 fatty acids can help, in addition to continuous oxygen saturation monitoring, to decrease the risk of ROP. We review this literature and provide a meta-analysis to evaluate the evidence.

Evaluation of hyperoxia-induced hypercapnia in obese patients after cardiac surgery: a randomized crossover comparison of conservative and liberal oxygen administration.

Recent studies on patients with stable obesity-hypoventilation syndrome have raised concerns about hyperoxia-induced hypercapnia in this population. This study aimed to evaluate whether a higher oxygen saturation target would increase arterial partial pressure of carbon dioxide (PaCO2) in obese patients after coronary artery bypass grafting surgery (CABG). Obese patients having CABG were recruited. With a randomized crossover design, we compared two oxygenation strategies for 30 min each, immediately after extubation:aperipheral oxygen saturation (SpO2)target of ≥ 95% achieved with manual oxygen titration (liberal) and a SpO2target of 90% achieved with FreeO2, an automated oxygen titration device (conservative). The main outcome was end-of-periodarterial PaCO2. Thirty patients were included. Mean (standard deviation [SD]) body mass index (BMI) was 34 (3) kg·m-2 and mean (SD) baseline partial pressure of carbon dioxide (PCO2) was 40.7 (3.1) mmHg. Mean (SD) end-of-period PaCO2 was 42.0 (5.4) mmHg in the conservative period, compared with 42.6 (4.6) mmHg in the liberal period [mean difference - 0.6 (95% confidence interval - 2.2 to 0.9) mmHg; P = 0.4]. Adjusted analysis for age, BMI, narcotics, and preoperative PaCO2 did not substantively change the results. Fourteen patients were retainers, showing an elevation in mean (SD) PaCO2 in the liberal period of 3.3 (4.1) mmHg. Eleven patients had the opposite response, with a mean (SD) end-of-period PaCO2 decrease of 1.8 (2.2) mmHg in the liberal period. Five patients had a neutral response. This study did not show a clinically important increase in PaCO2 associated with higher SpO2 values in this specific population of obese patients after CABG. Partial pressure of carbon dioxide increased with liberal oxygen administration in almost half of the patients, but no predictive factor was identified. www.clinicaltrials.gov (NCT02917668); registered 25 September, 2016.

Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants.

ObjectiveThe adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care.Design/Participants/SettingPubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions.ResultsWhile the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care.ConclusionsSUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these differences, are essential elements of adequate informed consent.

Respiratory Outcomes of the Surfactant Positive Pressure and Oximetry Randomized Trial (SUPPORT)

To explore the early childhood pulmonary outcomes of infants who participated in the National Institute of Child Health and Human Development's Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT), using a factorial design that randomized extremely preterm infants to lower vs higher oxygen saturation targets and delivery room continuous positive airway pressure (CPAP) vs intubation/surfactant. The Breathing Outcomes Study, a prospective secondary study to the Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial, assessed respiratory morbidity at 6-month intervals from hospital discharge to 18-22 months corrected age (CA). Two prespecified primary outcomes-wheezing more than twice per week during the worst 2-week period and cough longer than 3 days without a cold-were compared for each randomized intervention. One or more interviews were completed for 918 of the 922 eligible infants. The incidences of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between the study arms of either randomized intervention. Infants randomized to lower vs higher oxygen saturation targets had a similar risk of death or respiratory morbidity (except for croup and treatment with oxygen or diuretics at home). Infants randomized to CPAP vs intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs 36.5%; P<.05), respiratory illnesses diagnosed by a doctor (47.7% vs 55.2%; P<.05), and physician or emergency room visits for breathing problems (68.0% vs 72.9%; P<.05) by 18-22 months CA. Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18-22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates.

Timing of cord clamping in very preterm infants: more evidence is needed

In December 2012, the American College of Obstetricians and Gynecologists published a Committee Opinion entitled "Timing of umbilical cord clamping after birth." It stated that "evidence exists to support delayed cord clamping in preterm infants, when feasible. The single most important benefit for preterm infants is the possibility for a nearly 50% reduction in IVH." However, the Committee Opinion added that the ideal timing of umbilical cord clamping has yet to be determined and recommended that large clinical trials be conducted in the most preterm infants. Published randomized controlled trials include <200 infants of <30 weeks' gestation, with assessments of neurodevelopmental outcome in less than one-half of the children. This is a major gap in the evidence. Without reliable data from randomized controlled trials that optimally include childhood follow-up evaluations, we will not know whether delayed cord clamping may do more overall harm than good. Ongoing trials of delayed cord clamping plan to report childhood outcomes in >2000 additional very preterm infants. Current recommendations may need to change when these results become available. Greater international collaboration could accelerate resolution of whether this promising intervention will improve disability-free survival in about 1 million infants who will be born very preterm globally each year.

Optimal Oxygenation of Extremely Low Birth Weight Infants: A Meta-Analysis and Systematic Review of the Oxygen Saturation Target Studies

Background: The optimal oxygen saturation for extremely low birth weight infants in the postnatal period beyond the delivery room is not known. Objectives: To summarize and discuss the results of the randomized trials, constituting the NEOPROM (Neonatal Oxygenation Prospective Meta-analysis) collaborative study, examining the effect of low versus high functional oxygen saturation targets in the postnatal period in premature infants with gestational age <28 weeks. Methods: A meta-analysis of SUPPORT (Surfactant, Positive Pressure and Pulse Oximetry Randomized Trial), the three BOOST II (Benefits of Oxygen Saturation Targeting) studies and the COT (Canadian Oxygen Trial) was performed including a total of 4,911 infants randomized to either a low (85-89%) or high (91-95%) functional oxygen saturation (SpO₂) within the first 24 h after birth. Results: Relative risks (RR; 95% CIs) comparing a low versus a high oxygen saturation target were 1.41 (1.14-1.74) for mortality at discharge or at follow-up, 0.74 (0.59-0.92) for severe retinopathy of prematurity, 0.95 (0.86-1.04) for physiologic bronchopulmonary dysplasia, 1.25 (1.05-1.49) for necrotizing enterocolitis, 1.02 (0.88-1.19) for brain injury, and 1.01 (0.95-1.08) for patent ductus arteriosus. RR >1.0 favors a high oxygen saturation. Conclusions: RRs for mortality and necrotizing enterocolitis are significantly increased and severe retinopathy of prematurity significantly reduced in low compared to high oxygen saturation target infants. There are no differences regarding physiologic bronchopulmonary dysplasia, brain injury or patent ductus arteriosus between the groups. Based on these results, it is suggested that functional SpO₂ should be targeted at 90-95% in infants with gestational age <28 weeks until 36 weeks' postmenstrual age. However, there are still several unanswered questions in this field.

Increased 36 week survival with high oxygen saturation target in extremely preterm infants

BackgroundFive trials in infants <28 weeks' gestation are investigating outcomes after randomisation to SpO2 targets of 85–89% vs 91–95%. In the SUPPORT trial, the high target increased severe ROP (p<0.001)...

Increased 36-Week Survival with High Oxygen Saturation Target in Extremely Preterm Infants

The authors report pooled preliminary results from two trials of oxygen saturation (SpO2) targeting in infants born at less than 28 weeks of gestation.

Higher oxygen saturation targets did not improve growth and neurodevelopment in extremely preterm infants

Askie LM, Henderson-Smart DJ, Irwig L, et al . Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med 2003;349:959–67. [OpenUrl][1][CrossRef][2][PubMed][3][Web of Science][4] Q Does maintenance of higher...