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In extremely preterm infants, the use of cerebral oximetry monitoring to guide treatment for the first 72 hours after birth did not reduce the risk of death or severe brain injury at 36 weeks’ postmenstrual age.

Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry.Design Phase II randomised, single blinded, parallel clinical trial.Setting Eight tertiary neonatal intensive care units in eight European countries.Participants 166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support.Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control).Main outcome measures The primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography.Randomisation Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or ≥26 weeks).Blinding Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation.Results The 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P<0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 53.6 (17.4-171.3) %hours in the control group (P=0.0012). The median burden of hyperoxia was similar between the groups: 1.2 (interquartile range 0.3-9.6) %hours in the experimental group compared with 1.1 (0.1-23.4) %hours in the control group (P=0.98). We found no statistically significant differences between the two groups at term corrected age. No severe adverse reactions were associated with the device.Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring.Trial registration ClinicalTrial.gov NCT01590316.

Improving oxygen systems may improve clinical outcomes for hospitalised children with acute lower respiratory infection (ALRI). This paper reports the effects of an improved oxygen system on mortality and clinical practices in 12 general, paediatric, and maternity hospitals in southwest Nigeria. We conducted an unblinded stepped-wedge cluster-randomised trial comparing three study periods: baseline (usual care), pulse oximetry introduction, and stepped introduction of a multifaceted oxygen system. We collected data from clinical records of all admitted neonates (<28 days old) and children (28 days to 14 years old). Primary analysis compared the full oxygen system period to the pulse oximetry period and evaluated odds of death for children, children with ALRI, neonates, and preterm neonates using mixed-effects logistic regression. Secondary analyses included the baseline period (enabling evaluation of pulse oximetry introduction) and evaluated mortality and practice outcomes on additional subgroups. Three hospitals received the oxygen system intervention at 4-month intervals. Primary analysis included 7,716 neonates and 17,143 children admitted during the 2-year stepped crossover period (November 2015 to October 2017). Compared to the pulse oximetry period, the full oxygen system had no association with death for children (adjusted odds ratio [aOR] 1.06; 95% confidence interval [CI] 0.77-1.46; p = 0.721) or children with ALRI (aOR 1.09; 95% CI 0.50-2.41; p = 0.824) and was associated with an increased risk of death for neonates overall (aOR 1.45; 95% CI 1.04-2.00; p = 0.026) but not preterm/low-birth-weight neonates (aOR 1.30; 95% CI 0.76-2.23; p = 0.366). Secondary analyses suggested that the introduction of pulse oximetry improved oxygen practices prior to implementation of the full oxygen system and was associated with lower odds of death for children with ALRI (aOR 0.33; 95% CI 0.12-0.92; p = 0.035) but not for children, preterm neonates, or neonates overall (aOR 0.97, 95% CI 0.60-1.58, p = 0.913; aOR 1.12, 95% CI 0.56-2.26, p = 0.762; aOR 0.90, 95% CI 0.57-1.43, p = 0.651). Limitations of our study are a lower-than-anticipated power to detect change in mortality outcomes (low event rates, low participant numbers, high intracluster correlation) and major contextual changes related to the 2016-2017 Nigerian economic recession that influenced care-seeking and hospital function during the study period, potentially confounding mortality outcomes. We observed no mortality benefit for children and a possible higher risk of neonatal death following the introduction of a multifaceted oxygen system compared to introducing pulse oximetry alone. Where some oxygen is available, pulse oximetry may improve oxygen usage and clinical outcomes for children with ALRI. Australian New Zealand Clinical Trials Registry: ACTRN12617000341325.

Chronic obstructive pulmonary disease (COPD) is a progressive, chronic respiratory disease with a significant socioeconomic burden. Exacerbations, the sudden and sustained worsening of symptoms, can lead to hospitalization and reduce quality of life. Major limitations of previous telemonitoring interventions for COPD include low compliance, lack of consensus on what constitutes an exacerbation, limited numbers of patients, and short monitoring periods. We developed a telemonitoring system based on a digital health platform that was used to collect data from the 1-year EDGE (Self Management and Support Programme) COPD clinical trial aiming at daily monitoring in a heterogeneous group of patients with moderate to severe COPD. The objectives of the study were as follows: first, to develop a systematic and reproducible approach to exacerbation identification and to track the progression of patient condition during remote monitoring; and second, to develop a robust algorithm able to predict COPD exacerbation, based on vital signs acquired from a pulse oximeter. We used data from 110 patients, with a combined monitoring period of more than 35,000 days. We propose a finite-state machine-based approach for modeling COPD exacerbation to gain a deeper insight into COPD patient condition during home monitoring to take account of the time course of symptoms. A robust algorithm based on short-period trend analysis and logistic regression using vital signs derived from a pulse oximeter is also developed to predict exacerbations. On the basis of 27,260 sessions recorded during the clinical trial (average usage of 5.3 times per week for 12 months), there were 361 exacerbation events. There was considerable variation in the length of exacerbation events, with a mean length of 8.8 days. The mean value of oxygen saturation was lower, and both the pulse rate and respiratory rate were higher before an impending exacerbation episode, compared with stable periods. On the basis of the classifier developed in this work, prediction of COPD exacerbation episodes with 60%-80% sensitivity will result in 68%-36% specificity. All 3 vital signs acquired from a pulse oximeter (pulse rate, oxygen saturation, and respiratory rate) are predictive of COPD exacerbation events, with oxygen saturation being the most predictive, followed by respiratory rate and pulse rate. Combination of these vital signs with a robust algorithm based on machine learning leads to further improvement in positive predictive accuracy. International Standard Randomized Controlled Trial Number (ISRCTN): 40367841; http://www.isrctn.com/ISRCTN40367841 (Archived by WebCite at http://www.webcitation.org/6olpMWNpc).

ObjectiveTo determine the association between SpO2 at 5 min and preterm infant outcomes.DesignData from 768 infants <32 weeks gestation from 8 randomised controlled trials (RCTs) of lower (≤0.3) versus higher (≥0.6) initial inspiratory fractions of oxygen (FiO2) for resuscitation, were examined.SettingIndividual patient analysis of 8 RCTsInterventionsLower (≤0.3) versus higher (≥0.6) oxygen resuscitation strategies targeted to specific predefined SpO2 before 10 min of age.PatientsInfants <32 weeks gestation.Main outcome measuresRelationship between SpO2 at 5 min, death and intraventricular haemorrhage (IVH) >grade 3.Results5 min SpO2 data were obtained from 706 (92%) infants. Only 159 (23%) infants met SpO2 study targets and 323 (46%) did not reach SpO280%. Pooled data showed decreased likelihood of reaching SpO280% if resuscitation was initiated with FiO2 <0.3 (OR 2.63, 95% CI 1.21 to 5.74, p<0.05). SpO2 <80% was associated with lower heart rates (mean difference −8.37, 95% CI −15.73 to –1.01, *p<0.05) and after accounting for confounders, with IVH (OR 2.04, 95% CI 1.01 to 4.11, p<0.05). Bradycardia (heart rate <100 bpm) at 5 min increased risk of death (OR 4.57, 95% CI 1.62 to 13.98, p<0.05). Taking into account confounders including gestation, birth weight and 5 min bradycardia, risk of death was significantly increased with time taken to reach SpO280%.ConclusionNot reaching SpO280% at 5 min is associated with adverse outcomes, including IVH. Whether this is because of infant illness or the amount of oxygen that is administered during stabilisation is uncertain and needs to be examined in randomised trials

Abstract Objective To assess whether perioperative management guided by near-infrared spectroscopy to determine tissue oxygen saturation and haemodynamic monitoring reduces postoperative complications after off-pump coronary artery bypass grafting. Design Assessor blinded, single centre, randomised controlled trial (Bottomline-CS trial). Setting A tertiary teaching hospital in China. Participants 1960 patients aged 60 years or older who were scheduled for elective off-pump coronary artery bypass grafting. Interventions All patients had multisite monitoring of tissue oxygen saturation (bilateral forehead and unilateral forearm brachioradialis) and haemodynamic monitoring. Both groups received usual care, including arterial blood pressure, central venous pressure, electrocardiography, and transoesophageal echocardiography when indicated. Guided care aimed to maintain tissue oxygenation within 10% above or below preoperative baseline values, established 24-48 hours before surgery, from the start of anaesthesia until extubation or for up to 24 hours postoperatively. In the usual care group, tissue oximetry and haemodynamic data were concealed, and care was routine. Main outcome measures The primary outcome was the incidence of a composite of 30 day postoperative complications, which were cerebral, cardiac, respiratory, renal, infectious, and mortality complications. Secondary outcomes included the individual components of the composite outcome, new-onset atrial fibrillation, and hospital length of stay. Results Of 1960 patients randomly assigned, data from 967 guided care and 974 usual care patients were analysed. During anaesthesia, the area under the curve for tissue oxygen saturation measurements outside the plus and minus 10% baseline range was significantly smaller with guided care than only usual care: left forehead 32.4 versus 57.6 (%×min, P<0.001), right forehead 37.9 versus 62.6 (P<0.001), and forearm 14.8 versus 44.7 (P<0.001). The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83). No secondary outcomes differed significantly between groups. The largest observed difference was in incidence of pneumonia, which was less frequent in the guided care group (88/967, 9.1%) than in the usual care group (121/974, 12.4%) and not statistically significant after adjusting for multiple comparisons. Conclusions Guided care by use of multisite near-infrared spectroscopy and haemodynamic monitoring effectively maintained tissue oxygenation near baseline levels compared with usual care. However, no clear evidence was noted that this approach reduced the incidence of major postoperative complications. These findings do not support the routine use of near-infrared spectroscopy and haemodynamic monitoring to maintain tissue oxygenation during off-pump coronary artery bypass grafting. Trial registration ClinicalTrials.gov NCT04896736.

The American Academy of Pediatrics recommends a permissive hypoxaemic target for an oxygen saturation of 90% for children with bronchiolitis, which is consistent with the WHO recommendations for targets in children with lower respiratory tract infections. No evidence exists to support this threshold. We aimed to assess whether the 90% or higher target for management of oxygen supplementation was equivalent to a normoxic 94% or higher target for infants admitted to hospital with viral bronchiolitis. We did a parallel-group, randomised, controlled, equivalence trial of infants aged 6 weeks to 12 months of age with physician-diagnosed bronchiolitis newly admitted into eight paediatric hospital units in the UK (the Bronchiolitis of Infancy Discharge Study [BIDS]). A central computer randomly allocated (1:1) infants, in varying length blocks of four and six and without stratification, to be clipped to standard oximeters (patients treated with oxygen if pulse oxygen saturation [SpO2] <94%) or modified oximeters (displayed a measured value of 90% as 94%, therefore oxygen not given until SpO2 <90%). All parents, clinical staff, and outcome assessors were masked to allocation. The primary outcome was time to resolution of cough (prespecified equivalence limits of plus or minus 2 days) in the intention-to-treat population. This trial is registered with ISRCTN, number ISRCTN28405428. Between Oct 3, and March 30, 2012, and Oct 1, and March 29, 2013, we randomly assigned 308 infants to standard oximeters and 307 infants to modified oximeters. Cough resolved by 15·0 days (median) in both groups (95% CI for difference −1 to 2) and so oxygen thresholds were equivalent. We recorded 35 serious adverse events in 32 infants in the standard care group and 25 serious adverse events in 24 infants in the modified care group. In the standard care group, eight infants transferred to a high-dependency unit, 23 were readmitted, and one had a prolonged hospital stay. In the modified care group, 12 infants were transferred to a high-dependency unit and 12 were readmitted to hospital. Recorded adverse events did not differ significantly. Management of infants with bronchiolitis to an oxygen saturation target of 90% or higher is as safe and clinically effective as one of 94% or higher. Future research should assess the benefits and risks of different oxygen saturation targets in acute respiratory infection in older children, particularly in developing nations where resources are scarce. National Institute for Health Research, Health Technology Assessment programme.

Accurate assessment of vital parameters is essential for diagnosis and triage of critically ill patients, but not always feasible in out-of-hospital settings due to the lack of suitable devices. We performed an extensive validation of a novel prototype in-ear device, which was proposed for the non-invasive, combined measurement of core body temperature (Tc), oxygen saturation (SpO 2 ), and heart rate (HR) in harsh environments. A pilot study with randomized controlled design was conducted in the terraXcube environmental chamber. Participants were subsequently exposed to three 15 min test sessions at the controlled ambient temperatures of 20 °C, 5 °C, and − 10 °C, in randomized order. Vital parameters measured by the prototype were compared with Tc measurements from commercial esophageal (reference) and tympanic (comparator) probes and SpO 2 and HR measurements from a finger pulse-oximeter (reference). Performance was assessed in terms of bias and Lin’s correlation coefficient (CCC) with respect to the reference measurements and analyzed with linear mixed models. Twenty-three participants (12 men, mean (SD) age, 35 (9) years) completed the experimental protocol. The mean Tc bias of the prototype ranged between − 0.39 and − 0.80 °C at ambient temperatures of 20 °C and 5 °C, and it reached − 1.38 °C only after 15 min of exposure to − 10 °C. CCC values ranged between 0.07 and 0.25. SpO 2 and HR monitoring was feasible, although malfunctioning was observed in one third of the tests. SpO 2 and HR bias did not show any significant dependence on environmental conditions, with values ranging from − 1.71 to − 0.52% for SpO 2 and 1.12 bpm to 5.30 bpm for HR. High CCC values between 0.81 and 0.97 were observed for HR in all environmental conditions. This novel prototype device for measuring vital parameters in cold environments demonstrated reliability of Tc measurements and feasibility of SpO 2 and HR monitoring. Through non-invasive and accurate monitoring of vital parameters from the ear canal our prototype may offer support in triage and treatment of critically ill patients in harsh out-of-hospital conditions.

ObjectiveIn extremely preterm infants, different target ranges for pulse oximeter saturation (SpO2) may affect mortality and morbidity. Thus, the impact of technical changes potentially affecting measurements should be assessed. We studied SpO2 readings from different sensors for systematic deviations.DesignSingle-centre, randomised, triple crossover study.SettingTertiary neonatal intensive care unit.Patients24 infants, born at <32 weeks’ gestation, with current weight <1500 g and without right-to-left shunt via a patent ductus arteriosus.InterventionsSimultaneous readings from three SpO2 sensors (Red Diamond (RD), Photoplethysmography (PPG), Low Noise Cabled Sensors (LNCS)) were logged at 0.5 Hz over 6 hour/infant and compared with LNCS as control using analysis of variance. Sensor position was randomly allocated and rotated every 2 hours. Seven different batches each were used.OutcomesPrimary outcome was the difference in SpO2 readings. Secondary outcomes were differences between sensors in the proportion of time within the SpO2-target range (90–95 (100)%).ResultsMean gestational age at birth (±SD) was 274/7 (±23/7) weeks, postnatal age 20 (±20) days. 134 hours of recording were analysed. Mean SpO2 (±SD) was 94.0% (±3.8; LNCS) versus 92.2% (±4.0; RD; p<0.0001) and 94.5% (±3.9; PPG; p<0.0001), respectively. Mean SpO2 difference (95% CI) was −1.8% (−1.9 to −1.8; RD) and 0.5% (0.4 to 0.5; PPG). Proportion of time in target was significantly lower with RD sensors (84.8% vs 91.7%; p=0.0001) and similar with PPG sensors (91.1% vs 91.7%; p=0.63).ConclusionThere were systematic differences in SpO2 readings between RD sensors versus LNCS. These findings may impact mortality and morbidity of preterm infants, particularly when aiming for higher SpO2-target ranges (eg, 90–95%).Trial registration numberDRKS00027285.

In critically ill patients, endotracheal intubation (ETI) is lifesaving but carries a high risk of adverse events, notably hypoxemia. Preoxygenation is performed before introducing the tube to increase the safe apnea time. Oxygenation is monitored by pulse oximeter measurement of peripheral oxygen saturation (SpO2). However, SpO2 is unreliable at the high oxygenation levels produced by preoxygenation and, in the event of desaturation, may not decrease sufficiently early to allow preventive measures. The oxygen reserve index (ORI) is a dimensionless parameter that can also be measured continuously by a fingertip monitor and reflects oxygenation in the moderate hyperoxia range. The ORI ranges from 0 to 1 when arterial oxygen saturation (PaO2) varies between 100 to 200 mmHg, as occurs during preoxygenation. No trial has assessed the potential effects of ORI monitoring to guide preoxygenation for ETI in unstable patients. We designed a multicenter, two-arm, parallel-group, randomized, superiority, open trial in 950 critically ill adults requiring ETI. The intervention consists in monitoring ORI values and using an ORI target for preoxygenation of at least 0.6 for at least 1 minute. In the control group, preoxygenation is guided by SpO2 values recorded by a standard pulse oximeter, according to the standard of care, the goal being to obtain 100% SpO2 during preoxygenation, which lasts at least 3 minutes. The standard-of-care ETI technique is used in both arms. Baseline parameters, rapid-sequence induction medications, ETI devices, and physiological data are recorded. The primary outcome is the lowest SpO2 value from laryngoscopy to 2 minutes after successful ETI. Secondary outcomes include cognitive function on day 28. Assuming a 10% standard deviation for the lowest SpO2 value in the control group, no missing data, and crossover of 5% of patients, with the bilateral alpha risk set at 0.05, including 950 patients will provide 85% power for detecting a 2% between-group absolute difference in the lowest SpO2 value. Should ORI monitoring with a target of ≥0.6 be found to increase the lowest SpO2 value during ETI, then this trial may change current practice regarding preoxygenation for ETI. Trial registration: Registered on ClinicalTrials.gov (NCT05867875) on April 27, 2023.