Low versus high pulse oxygen saturation directed oxygen therapy in critically ill patients: a randomized controlled pilot study.
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ABSTRACT:
SUBMITTER: Yang X
PROVIDER: S-EPMC6837987 | biostudies-literature | 2019 Oct
REPOSITORIES: biostudies-literature
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Low versus high pulse oxygen saturation directed oxygen therapy in critically ill patients: a randomized controlled pilot study.
Yang Xiaobo X Shang You Y Yuan Shiying S
Journal of thoracic disease 20191001 10
<h4>Background</h4>Data on the safety and feasibility of pulse oxygen saturation (SpO<sub>2</sub>) directed oxygen therapy in mainland China are scarce. The aim of this pilot study was to test the feasibility of SpO<sub>2</sub> directed oxygen therapy and to calculate sample size base on differences in 28-day mortality rates for a large sample-sized randomized trial.<h4>Methods</h4>This prospective pilot study enrolled 214 adult patients with an expected intensive care unit (ICU) stay of more th ...[more]
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Project description:BackgroundInvasive mechanical ventilation in critically ill adults involves adjusting the fraction of inspired oxygen to maintain arterial oxygen saturation. The oxygen-saturation target that will optimize clinical outcomes in this patient population remains unknown.MethodsIn a pragmatic, cluster-randomized, cluster-crossover trial conducted in the emergency department and medical intensive care unit at an academic center, we assigned adults who were receiving mechanical ventilation to a lower target for oxygen saturation as measured by pulse oximetry (Spo2) (90%; goal range, 88 to 92%), an intermediate target (94%; goal range, 92 to 96%), or a higher target (98%; goal range, 96 to 100%). The primary outcome was the number of days alive and free of mechanical ventilation (ventilator-free days) through day 28. The secondary outcome was death by day 28, with data censored at hospital discharge.ResultsA total of 2541 patients were included in the primary analysis. The median number of ventilator-free days was 20 (interquartile range, 0 to 25) in the lower-target group, 21 (interquartile range, 0 to 25) in the intermediate-target group, and 21 (interquartile range, 0 to 26) in the higher-target group (P = 0.81). In-hospital death by day 28 occurred in 281 of the 808 patients (34.8%) in the lower-target group, 292 of the 859 patients (34.0%) in the intermediate-target group, and 290 of the 874 patients (33.2%) in the higher-target group. The incidences of cardiac arrest, arrhythmia, myocardial infarction, stroke, and pneumothorax were similar in the three groups.ConclusionsAmong critically ill adults receiving invasive mechanical ventilation, the number of ventilator-free days did not differ among groups in which a lower, intermediate, or higher Spo2 target was used. (Supported by the National Heart, Lung, and Blood Institute and others; PILOT ClinicalTrials.gov number, NCT03537937.).
| S-EPMC9724830 | biostudies-literature
Project description:BackgroundIn an intensive care units, experts in mechanical ventilation are not continuously at patient's bedside to adjust ventilation settings and to analyze the impact of these adjustments on gas exchange. The development of clinical decision support systems analyzing patients' data in real time offers an opportunity to fill this gap.ObjectiveThe objective of this study was to determine whether a machine learning predictive model could be trained on a set of clinical data and used to predict transcutaneous hemoglobin oxygen saturation 5 min (5min SpO2) after a ventilator setting change.Data sourcesData of mechanically ventilated children admitted between May 2015 and April 2017 were included and extracted from a high-resolution research database. More than 776,727 data rows were obtained from 610 patients, discretized into 3 class labels (< 84%, 85% to 91% and c92% to 100%).Performance metrics of predictive modelsDue to data imbalance, four different data balancing processes were applied. Then, two machine learning models (artificial neural network and Bootstrap aggregation of complex decision trees) were trained and tested on these four different balanced datasets. The best model predicted SpO2 with area under the curves < 0.75.ConclusionThis single center pilot study using machine learning predictive model resulted in an algorithm with poor accuracy. The comparison of machine learning models showed that bagged complex trees was a promising approach. However, there is a need to improve these models before incorporating them into a clinical decision support systems. One potentially solution for improving predictive model, would be to increase the amount of data available to limit over-fitting that is potentially one of the cause for poor classification performances for 2 of the three class labels.
| S-EPMC6382156 | biostudies-literature
Project description:BackgroundCentral venous oxygen saturation (ScvO2) is often used to help to guide resuscitation of critically ill patients. The standard gold technique for ScvO2 measurement is the co-oximetry (Co-oximetry_ScvO2), which is usually incorporated in most recent blood gas analyzers. However, in some hospitals, those machines are not available and only calculated ScvO2 (Calc_ScvO2) is provided. Therefore, we aimed to investigate the agreement between Co-oximetry_ScvO2 and Calc_ScvO2 in a general population of critically ill patients and septic shock patients.MethodsA total of 100 patients with a central venous catheter were included in the study. One hundred central venous blood samples were collected and analyzed using the same point-of-care blood gas analyzer, which provides both the calculated and measured ScvO2 values. Bland and Altman plot, intra-class correlation coefficient (ICC), and Cohen's Kappa coefficient were used to assess the agreement between Co-oximetry_ScvO2 and Calc_ScvO2. Multiple linear regression analysis was performed to investigate the independent explanatory variables of the difference between Co-oximetry_ScvO2 and Calc_ScvO2.ResultsIn all population, Bland and Altman's analysis showed poor agreement (+4.5 [-7.1, +16.1]%) between the two techniques. The ICC was 0.754 [(95% CI: 0.393-0.880), P< 0.001], and the Cohen's Kappa coefficient, after categorizing the two variables into two groups using a cutoff value of 70%, was 0.470 (P <0.001). In septic shock patients (49%), Bland and Altman's analysis also showed poor agreement (+5.6 [-6.7 to 17.8]%). The ICC was 0.720 [95% CI: 0.222-0.881], and the Cohen's Kappa coefficient was 0.501 (P <0.001). Four independent variables (PcvO2, Co-oximetry_ScvO2, venous pH, and Hb) were found to be associated with the difference between the measured and calculated ScvO2 (adjusted R2 = 0.8, P<0.001), with PcvO2 being the main independent explanatory variable because of its highest absolute standardized coefficient. The area under the receiver operator characteristic curves (AUC) of PcvO2 to predict Co-oximetry_ScvO2 ? 70% was 0.911 [95% CI: 0.837-0.959], in all patients, and 0.903 [95% CI: 0.784-0.969], in septic shock patients. The best cutoff value was ? 36 mmHg (sensitivity, 88%; specificity, 83%), in all patients, and ? 35 mmHg (sensitivity, 94%; specificity, 71%) in septic shock patients.ConclusionsThe discrepancy between the measured and calculated ScvO2 is clinically not acceptable. We do not recommend the use of calculated ScvO2 to guide resuscitation in critically ill patients. In situations where the Co-oximetry technique is not available, relying on PcvO2 to predict the measured ScvO2 value above or below 70% could be an option.
| S-EPMC6224192 | biostudies-literature
Project description:BACKGROUND:In the critically ill, energy delivery from enteral nutrition (EN) is often less than the estimated energy requirement. Parenteral nutrition (PN) as a supplement to EN may increase energy delivery. We aimed to determine if an individually titrated supplemental PN strategy commenced 48-72 hours following ICU admission and continued for up to 7 days would increase energy delivery to critically ill adults compared to usual care EN delivery. METHODS:This study was a prospective, parallel group, phase II pilot trial conducted in six intensive care units in Australia and New Zealand. Mechanically ventilated adults with at least one organ failure and EN delivery below 80% of estimated energy requirement in the previous 24 hours received either a supplemental PN strategy (intervention group) or usual care EN delivery. EN in the usual care group could be supplemented with PN if EN remained insufficient after usual methods to optimise delivery were attempted. RESULTS:There were 100 patients included in the study and 99 analysed. Overall, 71% of the study population were male, with a mean (SD) age of 59 (17) years, Acute Physiology and Chronic Health Evaluation II score of 18.2 (6.7) and body mass index of 29.6 (5.8) kg/m2. Significantly greater energy (mean (SD) 1712 (511) calories vs. 1130 (601) calories, p?<?0.0001) and proportion of estimated energy requirement (mean (SD) 83 (25) % vs. 53 (29) %, p?<?0.0001) from EN and/or PN was delivered to the intervention group compared to usual care. Delivery of protein and proportion of estimated protein requirements were also greater in the intervention group (mean (SD) 86 (25) g, 86 (23) %) compared to usual care (mean (SD) 53 (29) g, 51 (25) %, p?<?0.0001). Antibiotic use, ICU and hospital length of stay, mortality and functional outcomes were similar between the two groups. CONCLUSIONS:This individually titrated supplemental PN strategy applied over 7 days significantly increased energy delivery when compared to usual care delivery. Clinical and functional outcomes were similar between the two patient groups. TRIAL REGISTRATION:Clinical Trial registry details: NCT01847534 (First registered 22 April 2013, last updated 31 July 2016).
| S-EPMC5781264 | biostudies-literature
Project description:Recent studies have found that oxygen saturation (SpO2 ) variability analysis has potential for noninvasive assessment of the functional connectivity of cardiorespiratory control systems during hypoxia. Patients with sepsis have suboptimal tissue oxygenation and impaired organ system connectivity. Our objective with this report was to highlight the potential use for SpO2 variability analysis in predicting intensive care survival in patients with sepsis. MIMIC-III clinical data of 164 adults meeting Sepsis-3 criteria and with 30 min of SpO2 and respiratory rate data were analyzed. The complexity of SpO2 signals was measured through various entropy calculations such as sample entropy and multiscale entropy analysis. The sequential organ failure assessment (SOFA) score was calculated to assess the severity of sepsis and multiorgan failure. While the standard deviation of SpO2 signals was comparable in the non-survivor and survivor groups, non-survivors had significantly lower SpO2 entropy than those who survived their ICU stay (0.107 ± 0.084 vs. 0.070 ± 0.083, p < 0.05). According to Cox regression analysis, higher SpO2 entropy was a predictor of survival in patients with sepsis. Multivariate analysis also showed that the prognostic value of SpO2 entropy was independent of other covariates such as age, SOFA score, mean SpO2 , and ventilation status. When SpO2 entropy was combined with mean SpO2 , the composite had a significantly higher performance in prediction of survival. Analysis of SpO2 entropy can predict patient outcome, and when combined with SpO2 mean, can provide improved prognostic information. The prognostic power is on par with the SOFA score. This analysis can easily be incorporated into current ICU practice and has potential for noninvasive assessment of critically ill patients.
| S-EPMC9768724 | biostudies-literature
Project description:BackgroundSerum lactate and central venous oxygen saturation (ScvO2) are commonly used and commonly recommended as markers of tissue oxygenation in shock states. Medical literature has both explicitly stated and implied that the two biomarkers are interchangeable in the management of patients with shock. However, there have been relatively few direct comparisons of these tests in clinical circumstances, and the relationship between them is uncertain. The objective of our study was to evaluate whether simultaneous or near-simultaneous measurements of lactate and ScvO2 reveal a consistent relationship between these two biomarkers.MethodsA retrospective cohort study was conducted in an urban, academic US hospital. All adults in ICUs between March 2007 and March 2017 who had a lactate measurement and ScvO2 or mixed venous oxygen saturation (SvO2) measurement made +/- 1 h from the lactate were included. Linear and non-linear correlations of ScvO2 and lactate were assessed in a variety of shock states.ResultsTwo thousand sixty-two patients were included. Lactate and ScvO2 correlated poorly (r 2 = 0.0041, p = 0.0019). This was true for patients with ScvO2 ≤ 65% (r 2 = 0.0431, p < 0.001), patients with normal kidney and liver function (r 2 = 0.0517, p < 0.001), and septic shock patients (r 2 = 0.0037, p = 0.17). For patients with an O2 extraction ratio ≥ 50%, lactate and ScvO2 were strongly correlated (r 2 = 0.93, p = 0.0019), but these patients represented only 2.8% of patients in whom the ratio could be calculated.ConclusionsLactate can predict ScvO2 when patients are at or below the critical oxygen delivery threshold, but relatively few shock patients meet this criterion. In the overall population of critically ill patients, serum lactate predicts ScvO2 poorly, even after controlling for factors that may affect lactate production. Lactate and ScvO2 should not be assumed to be interchangeable markers of tissue oxygenation/perfusion.
| S-EPMC6728973 | biostudies-literature
Project description:BackgroundMonitoring systems have been developed during the COVID-19 pandemic enabling clinicians to remotely monitor physiological measures including pulse oxygen saturation (SpO2), heart rate (HR), and breathlessness in patients after discharge from hospital. These data may be leveraged to understand how symptoms vary over time in COVID-19 patients. There is also potential to use remote monitoring systems to predict clinical deterioration allowing early identification of patients in need of intervention.MethodsA remote monitoring system was used to monitor 209 patients diagnosed with COVID-19 in the period following hospital discharge. This system consisted of a patient-facing app paired with a Bluetooth-enabled pulse oximeter (measuring SpO2 and HR) linked to a secure portal where data were available for clinical review. Breathlessness score was entered manually to the app. Clinical teams were alerted automatically when SpO2 < 94 %. In this study, data recorded during the initial ten days of monitoring were retrospectively examined, and a random forest model was developed to predict SpO2 < 94 % on a given day using SpO2 and HR data from the two previous days and day of discharge.ResultsOver the 10-day monitoring period, mean SpO2 and HR increased significantly, while breathlessness decreased. The coefficient of variation in SpO2, HR and breathlessness also decreased over the monitoring period. The model predicted SpO2 alerts (SpO2 < 94 %) with a mean cross-validated. sensitivity of 66 ± 18.57 %, specificity of 88.31 ± 10.97 % and area under the receiver operating characteristic of 0.80 ± 0.11. Patient age and sex were not significantly associated with the occurrence of asymptomatic SpO2 alerts.ConclusionResults indicate that SpO2 alerts (SpO2 < 94 %) on a given day can be predicted using SpO2 and heart rate data captured on the two preceding days via remote monitoring. The methods presented may help early identification of patients with COVID-19 at risk of clinical deterioration using remote monitoring.
| S-EPMC9625852 | biostudies-literature
Project description:ObjectiveThe aim of the current study was to investigate how cerebral and splanchnic oxygen saturation (rSO2-C and rSO2-A) in critically ill children transported in air ambulance was affected by flight with cabin pressurization corresponding to ≥ 5000 feet. A second aim was to investigate any differences between cyanotic and non-cyanotic children in relation to cerebral and splanchnic oxygen saturation during flight ≥ 5000 feet. The variability of the cerebral and splanchnic Near Infrared Spectroscopy (NIRS) sensors was evaluated.DesignNIRS was used to measure rSO2-C and rSO2-A during transport of critically ill children in air ambulance. rSO2 data was collected and stored by the NIRS monitor and extracted and analyzed off-line after the transport. Prior to evaluation of the NIRS signals all zero and floor-effect values were removed.SettingThe Pediatric Intensive Care Unit (PICU) at Astrid Lindgren Children's Hospital, Karolinska University Hospital in Stockholm, Sweden.PatientsIn total, 44 critically ill children scheduled for inter-hospital transport by a specialized pediatric transport team were included in the study between January 2014 and January 2019 (convenience sampling).InterventionNo interventions were conducted.MeasurementsAll study patients were monitored with a cerebral NIRS-sensor placed over the forehead and an abdominal NIRS-sensor placed in the infra-umbilical area for cerebral and splanchnic regional oxygen saturation monitoring, rSO2-C and rSO2-A, respectively.Main resultsComplete rSO2-C and rSO2-A data was obtained in 39 patients. Median age was 12 days. Cyanotic congenital heart malformations were present in 9 patients (23%). In 22 patients (56%) rSO2-C decreased at altitude ≥ 5000 feet and in 24 patients (61%) rSO2-A decreased at altitude ≥ 5000 feet compared to baseline (p<0.0001). In 25 patients (64%) the rSO2-C/rSO2-A ratio was greater at altitude ≥ 5000 feet than at baseline. A ratio ≥ 1 was seen in 77% of patients at altitude ≥ 5000 feet compared to in 67% of patients at baseline.ConclusionBoth cerebral and splanchnic oxygen saturation decreased at altitude ≥ 5000 feet compared to baseline. In most patients, both cyanotic and non-cyanotic, cerebral oxygen saturation was preserved more than splanchnic oxygen saturation.
| S-EPMC7518599 | biostudies-literature
Project description:IntroductionProtein-energy malnutrition, increased catabolism and inadequate nutritional support leads to loss of lean body mass with muscle wasting and delayed recovery in critical illness. However, there remains clinical equipoise regarding the risks and benefits of protein supplementation. This pilot trial will determine the feasibility of performing a larger multicentre trial to determine if a strategy of protein supplementation in critically ill children with body mass index (BMI) z-score ≤-2 is superior to standard enteral nutrition in reducing the length of stay in the paediatric intensive care unit (PICU).Methods and analysisThis is a randomised controlled trial of 70 children in two PICUs in Singapore. Children with BMI z-score ≤-2 on PICU admission, who are expected to require invasive mechanical ventilation for more than 48 hours, will be randomised (1:1 allocation) to protein supplementation of ≥1.5 g/kg/day in addition to standard nutrition, or standard nutrition alone for 7 days after enrolment or until PICU discharge, whichever is earlier. Feasibility outcomes for the trial include effective screening, satisfactory enrolment rate, timely protocol implementation (within first 72 hours) and protocol adherence. Secondary outcomes include mortality, PICU length of stay, muscle mass, anthropometric measurements and functional outcomes.Ethics and disseminationThe trial protocol was approved by the institutional review board of both participating centres (Singhealth Centralised Institutional Review Board and National Healthcare Group Domain Specific Review Board) under the reference number 2020/2742. Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.Trial registration numberNCT04565613.
| S-EPMC8728412 | biostudies-literature
Project description:For critically ill adults, oxygen saturation is continuously monitored using pulse oximetry (Spo2) as a surrogate for arterial oxygen saturation (Sao2). Skin pigmentation may affect accuracy of Spo2 by introducing error from statistical bias, variance, or both. We evaluated relationships between race, Spo2, Sao2, and hypoxemia (Sao2 < 88%) or hyperoxemia (Pao2 > 150 mm Hg) among adults receiving mechanical ventilation in a medical ICU.DesignSingle-center, observational study.SettingMedical ICU at an academic medical center.PatientsCritically ill adults receiving mechanical ventilation from July 2018 to February 2021, excluding patients with COVID-19, with race documented as Black or White in the electronic medical record, who had a pair of Spo2 and Sao2 measurements collected within 10 minutes of each other.InterventionsNone.MeasurementsWe included 1,024 patients with 5,557 paired measurements within 10 minutes, of which 3,885 (70%) were within 1 minute. Of all pairs, 769 (14%) were from Black patients and 4,788 (86%) were from White patients. In analyses using a mixed-effects model, we found that across the range of Spo2 values of 92-98%, the associated Sao2 value was approximately 1% point lower for Black patients compared with White patients. Among patients with a Spo2 value between 92% and 96%, Black patients were more likely to have both hypoxemia (3.5% vs 1.1%; p = 0.002) and hyperoxemia (4.7% vs 2.4%; p = 0.03), compared with White patients.ConclusionsAmong patients with a measured Spo2 of 92-96%, greater variation in Sao2 values at a given Spo2 resulted in a higher occurence rate of both hypoxemia and hyperoxemia for Black patients compared with White patients.
| S-EPMC9478292 | biostudies-literature