Liberal versus conservative oxygen therapy in critically ill patients: using the fragility index to determine robust results.
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ABSTRACT:
SUBMITTER: Vargas M
PROVIDER: S-EPMC6474041 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
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Liberal versus conservative oxygen therapy in critically ill patients: using the fragility index to determine robust results.
Vargas Maria M Servillo Giuseppe G
Critical care (London, England) 20190418 1
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Project description:IntroductionOptimal targets for systemic oxygenation in paediatric critical illness are unknown. Observational data indicate that high levels of arterial oxygenation are associated with poor outcomes in resuscitation of the newborn and in adult critical illness. Within paediatric intensive care units (PICUs), staff prevent severe hypoxia wherever possible, but beyond this there is no consensus. Practice varies widely with age, diagnosis, treating doctor and local or national guidelines followed, though peripheral blood oxygen saturations (SpO2) of >95% are often targeted. The overall aim of this pilot study is to determine the feasibility of performing a randomised trial in critically ill children comparing current practice of liberal SpO2 targets with a more conservative target.Methods and analysisOxy-PICU is a pragmatic, open, pilot randomised controlled trial in infants and children requiring mechanical ventilation and receiving supplemental oxygen for abnormal gas exchange accepted for emergency admission to one of three participating UK PICUs. The study groups will be either a conservative SpO2 target of 88%-92% (inclusive) or a liberal SpO2 target of >94%. Infants and children who fulfil all inclusion criteria and none of the exclusion criteria will be randomised 1:1 by a secure web-based system to one of the two groups. Baseline demographics and clinical status will be recorded as well as daily measures of oxygenation and organ support. Discharge outcomes will also be recorded. In addition to observational data, blood and urine samples will be taken to identify biochemical markers of oxidative stress. Outcomes are targeted at assessing study feasibility with a primary outcome of adequate study recruitment (target: 120 participants).Ethics and disseminationThe trial received Health Research Authority approval on 1 June 2017 (16/SC/0617). Study findings will be disseminated in national and international conferences and peer-reviewed journals.Trial registration numberNCT03040570.
| S-EPMC5736024 | biostudies-literature
Project description:ObjectiveConservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies' effect and safety in ICU patients.MethodsWe searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome.ResultsWe included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97-1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05-1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies.ConclusionsOur findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.
| S-EPMC8295978 | biostudies-literature
Project description:ObjectivesSepsis-associated encephalopathy (SAE) patients in the intensive care unit (ICU) and perioperative period are administrated supplemental oxygen. However, the correlation between oxygenation status with SAE and the target for oxygen therapy remains unclear. This study aimed to examine the relationship between oxygen therapy and SAE patients.MethodsPatients diagnosed with sepsis 3.0 in the intensive care unit (ICU) were enrolled. The data were collected from the Medical Information Mart for Intensive Care IV (MIMIC IV) database and the eICU Collaborative Research Database (eICU-CRD) database. The generalized additive models were adopted to estimate the oxygen therapy targets in SAE patients. The results were confirmed by multivariate Logistic, propensity score analysis, inversion probability-weighting, doubly robust model, and multivariate COX analyses. Survival was analyzed by the Kaplan-Meier method.ResultsA total of 10055 patients from eICU-CRD and 1685 from MIMIC IV were included. The incidence of SAE patients was 58.43%. The range of PaO2 (97-339) mmHg, PaO2/FiO2 (189-619), and SPO2≥93% may reduce the incidence of SAE, which were verified by multivariable Logistic regression, propensity score analysis, inversion probability-weighting, and doubly robust model estimation in MIMIC IV database and eICU database. The range of PaO2/FiO2 (189-619) and SPO2≥93% may reduce the hospital mortality of SAE were verified by multivariable COX regression.ConclusionsSAE patients in ICU, including perioperative period, require conservative oxygen therapy. We should maintain SPO2≥93%, PaO2 (97-339) mmHg and PaO2/FiO2 (189-619) in SAE patients.
| S-EPMC9626799 | biostudies-literature
Project description:PurposePatients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) frequently develop arterial hyperoxaemia, which may be harmful. However, lower oxygen saturation targets may also lead to harmful episodes of hypoxaemia.MethodsIn this registry-embedded, multicentre trial, we randomly assigned adult patients receiving VA-ECMO in an intensive care unit (ICU) to either a conservative (target SaO2 92-96%) or to a liberal oxygen strategy (target SaO2 97-100%) through controlled oxygen administration via the ventilator and ECMO gas blender. The primary outcome was the number of ICU-free days to day 28. Secondary outcomes included ICU-free days to day 60, mortality, ECMO and ventilation duration, ICU and hospital lengths of stay, and functional outcomes at 6 months.ResultsFrom September 2019 through June 2023, 934 patients who received VA-ECMO were reported to the EXCEL registry, of whom 300 (192 cardiogenic shock, 108 refractory cardiac arrest) were recruited. We randomised 149 to a conservative and 151 to a liberal oxygen strategy. The median number of ICU-free days to day 28 was similar in both groups (conservative: 0 days [interquartile range (IQR) 0-13.7] versus liberal: 0 days [IQR 0-13.7], median treatment effect: 0 days [95% confidence interval (CI) - 3.1 to 3.1]). Mortality at day 28 (59/159 [39.6%] vs 59/151 [39.1%]) and at day 60 (64/149 [43%] vs 62/151 [41.1%] were similar in conservative and liberal groups, as were all other secondary outcomes and adverse events. The conservative group experienced 44 (29.5%) major protocol deviations compared to 2 (1.3%) in the liberal oxygen group (P < 0.001).ConclusionsIn adults receiving VA-ECMO in ICU, a conservative compared to a liberal oxygen strategy, did not affect the number of ICU-free days to day 28.
| S-EPMC11377512 | biostudies-literature
Project description:BackgroundHyperoxia is associated with increased morbidity and mortality in the intensive care unit. Classical noninvasive measurements of oxygen saturation with pulse oximeters are unable to detect hyperoxia. The Oxygen Reserve Index (ORI) is a continuous noninvasive parameter provided by a multi-wave pulse oximeter that can detect hyperoxia. Primary objective was to evaluate the diagnostic accuracy of the ORI for detecting arterial oxygen tension (PaO2) > 100 mmHg in neurocritical care patients. Secondary objectives were to test the ability of ORI to detect PaO2 > 120 mmHg and the ability of pulse oximetry (SpO2) to detect PaO2 > 100 mmHg and PaO2 > 120 mmHg.MethodsIn this single-center study, we collected ORI and arterial blood samples every 6 h for 3 consecutive days. Diagnostic performance was estimated using the area under the receiver operating characteristic curve (AUROC).ResultsThere were 696 simultaneous measurements of ORI and PaO2 in 62 patients. Considering the repeated measurements, the correlation between ORI and PaO2 was r = 0.13. The area under the receiver operating characteristic curve (AUROC), obtained to test the ability of ORI to detect PaO2 > 100 mmHg, was 0.567 (95% confidence interval = 0.566-0.569) with a sensitivity of 0.233 (95%CI = 0.230-0.235) and a specificity of 0.909 (95%CI = 0.907-0.910). The AUROC value obtained to test the ability of SpO2 to detect a PaO2 > 100 mmHg was 0.771 (95%CI = 0.770-0.773) with a sensitivity of 0.715 (95%CI = 0.712-0.718) and a specificity of 0.700 (95%CI = 0.697-0.703). The diagnostic performance of ORI and SpO2 for detecting PaO2 > 120 mmHg was AUROC = 0.584 (95%CI = 0.582-0.586) and 0.764 (95%CI = 0.762-0.766), respectively. The AUROC obtained for SpO2 was significantly higher than that for ORI (p < 0.01). Diagnostic performance was not affected by sedation, norepinephrine infusion, arterial partial pressure of carbon dioxide, hemoglobin level and perfusion index.ConclusionIn a specific population of brain-injured patients hospitalized in a neurointensive care unit, our results suggest that the ability of ORI to diagnose hyperoxia is relatively low and that SpO2 provides better detection.
| S-EPMC9110610 | biostudies-literature
Project description:Oxygen supplementation is one of the most common interventions in critically ill patients. Despite over a century of data suggesting both beneficial and detrimental effects of supplemental oxygen, optimal arterial oxygenation targets in adult patients remain unclear. Laboratory animal studies have consistently showed that exposure to a high FiO2 causes respiratory failure and early death. Human autopsy studies from the 1960s purported to provide histologic evidence of pulmonary oxygen toxicity in the form of diffuse alveolar damage. However, concomitant ventilator-induced lung injury and/or other causes of acute lung injury may explain these findings. Although some observational studies in general populations of critically adults showed higher mortality in association with higher oxygen exposures, this finding has not been consistent. For some specific populations, such as those with cardiac arrest, studies have suggested harm from targeting supraphysiologic PaO2 levels. More recently, randomized clinical trials of arterial oxygenation targets in narrower physiologic ranges were conducted in critically ill adult patients. Although two smaller trials came to opposite conclusions, the two largest of these trials showed no differences in clinical outcomes in study groups that received conservative versus liberal oxygen targets, suggesting that either strategy is reasonable. It is possible that some strategies are of benefit in some subpopulations, and this remains an important ongoing area of research. Because of the ubiquity of oxygen supplementation in critically ill adults, even small treatment effects could have a large impact on a global scale.
| S-EPMC8521700 | biostudies-literature
Project description:BackgroundSedation of intensive care patients is needed for patient safety, but deep sedation is associated with adverse outcomes. Frontal electromyogram-based Responsiveness Index (RI) aims to quantify the level of sedation and is scaled 0-100 (low index indicates deep sedation). We compared RI-based sedation to Richmond Agitation-Sedation Scale- (RASS-) based sedation. Our hypothesis was that RI-controlled sedation would be associated with increased total time alive without mechanical ventilation at 30 days without an increased number of adverse events.Methods32 critically ill adult patients with mechanical ventilation and administration of sedation were randomized to either RI- or RASS-guided sedation. Patients received propofol and oxycodone, if possible. The following standardized sedation protocol was utilized in both groups to achieve the predetermined target sedation level: either RI 40-80 (RI group) or RASS -3 to 0 (RASS group). RI measurement was blinded in the RASS group, and the RI group was blinded to RASS assessments. State Entropy (SE) values were registered in both groups.ResultsRI and RASS groups did not differ in total time alive in 30 days without mechanical ventilation (p=0.72). The incidence of at least one sedation-related adverse event did not differ between the groups. Hypertension was more common in the RI group (p=0.01). RI group patients were in the target RI level 22% of the time and RASS group patients had 57% of scores within the target RASS level. The RI group spent significantly more time in their target sedation level than the RASS group spent in the corresponding RI level (p=0.03). No difference was observed between the groups (p=0.13) in the corresponding analysis for RASS. Propofol and oxycodone were administered at higher RI and SE values and lower RASS values in the RI group than in the RASS group.ConclusionFurther studies with a larger sample size are warranted to scrutinize the optimal RI level during different phases of critical illness.
| S-EPMC8516552 | biostudies-literature
Project description:Whether low peripheral oxygen saturation (SpO2) directed oxygen therapy is associated with lower mortality in critically ill patients needs further exploration. Adult critically ill patients from 11 intensive care units in China were screened. Participants were randomly assigned to the low SpO2 (90%-95%) group or the high SpO2 (≥96%) -group. The primary outcome was 28-day all-cause mortality. The secondary outcomes were hours free from ventilators and from renal replacement therapy (RRT) within 14 days. Note that 857 patients in the low SpO2 group and 849 in the high SpO2 group were included. In the low SpO2 group versus the high SpO2 group, the time-weighted average of the fraction of inspired oxygen (FiO2) was significantly lower (33.5 ± 9.7% vs. 39.6 ± 9.3%, p < 0.001), and so was the time-weighted average of SpO2 (95.9 ± 1.8% vs. 98.0 ± 1.9%, p < 0.001). Within 28 days after randomization, 172 (20.1%) in the low SpO2 group and 193 (22.7%) in the high SpO2 group died (p = 0.180). Ventilator-free time and RRT-free time were not significantly different within 14 days. In critically ill patients, low SpO2directed oxygen therapy did not decrease 28-day mortality, 14-day ventilator-free time, or 14-day RRT-free time.
| S-EPMC11831183 | biostudies-literature
Project description:BackgroundData on the safety and feasibility of pulse oxygen saturation (SpO2) directed oxygen therapy in mainland China are scarce. The aim of this pilot study was to test the feasibility of SpO2 directed oxygen therapy and to calculate sample size base on differences in 28-day mortality rates for a large sample-sized randomized trial.MethodsThis prospective pilot study enrolled 214 adult patients with an expected intensive care unit (ICU) stay of more than 72 hours. Patients were randomized into a low SpO2 group (SpO2 90-95%) or high SpO2 group (SpO2 96-100%). The primary outcome was 28-day mortality.ResultsOne hundred patients were included in the low SpO2 group, and 114 patients were included in the high SpO2 group. The demographic and baseline characteristics were not different. The time-weighted SpO2 average was significantly lower in the low SpO2 group than in the high SpO2 group [mean ± standard deviation (SD), 95.7%±2.3% vs. 98.2%±1.8%, P<0.001]. Twenty-six patients (26%) in the low SpO2 group died within 28 days after inclusion, while 37 patients (32.5%) in the high SpO2 group died (P=0.301). The time to death within 28 days between the two groups was not different (P=0.284).ConclusionsSpO2 directed oxygen therapy in critically ill patients was feasible. Our pilot trial necessitates and rationalizes our large-sample multicenter trial.
| S-EPMC6837987 | biostudies-literature
Project description:Oxygen consumption may be impaired in critically ill patients.To evaluate the effect of intravenous thiamine on oxygen consumption ([Formula: see text]o2) in critically ill patients.This was a small, exploratory open-label pilot study conducted in the intensive care units at a tertiary care medical center. Critically ill adults requiring mechanical ventilation were screened for enrollment. Oxygen consumption ([Formula: see text]o2) and cardiac index (CI) were recorded continuously for 9 hours. After 3 hours of baseline data collection, 200 mg of intravenous thiamine was administered. The outcome was change in [Formula: see text]o2 after thiamine administration.Twenty patients were enrolled and 3 were excluded because of incomplete [Formula: see text]o2 data, leaving 17 patients for analysis. There was a trend toward increase in [Formula: see text]o2 after thiamine administration (16.3 ml/min, SE 8.5; P?=?0.052). After preplanned adjustment for changes in CI in case of a delivery-dependent state in some patients (with exclusion of one additional patient because of missing CI data), this became statistically significant (16.9 ml/min, SE 8.6; P?=?0.047). In patients with average CI greater than our cohort's mean value of 3 L/min/m(2), [Formula: see text]o2 increased by 70.9 ml/min (±16; P?<?0.0001) after thiamine. Thiamine had no effect in patients with reduced CI (<?2.4 L/min/m(2)). There was no association between initial thiamine level and change in [Formula: see text]o2 after thiamine administration.The administration of a single dose of thiamine was associated with a trend toward increase in [Formula: see text]o2 in critically ill patients. There was a significant increase in [Formula: see text]o2 in those patients with preserved or elevated CI. Further study is needed to better characterize the role of thiamine in oxygen extraction. Clinical trial registered with www.clinicaltrials.gov (NCT01462279).
| S-EPMC4298978 | biostudies-literature