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This study investigated the long-term effects of humidified high-flow nasal cannula (HFNC) in COPD patients with chronic hypoxemic respiratory failure treated with long-term oxygen therapy (LTOT). A total of 200 patients were randomized into usual care ± HFNC. At inclusion, acute exacerbation of COPD (AECOPD) and hospital admissions 1 year before inclusion, modified Medical Research Council (mMRC) score, St George's Respiratory Questionnaire (SGRQ), forced expiratory volume in 1 second (FEV ), 6-minute walk test (6MWT) and arterial carbon dioxide (PaCO ) were recorded. Patients completed phone interviews at 1, 3 and 9 months assessing mMRC score and AECOPD since the last contact. At on-site visits (6 and 12 months), mMRC, number of AECOPD since last contact and SGRQ were registered and FEV , FEV %, PaCO and, at 12 months, 6MWT were reassessed. Hospital admissions during the study period were obtained from hospital records. Hours of the use of HFNC were retrieved from the high-flow device. The average daily use of HFNC was 6 hours/day. The HFNC group had a lower AECOPD rate (3.12 versus 4.95/patient/year, <0.001). Modeled hospital admission rates were 0.79 versus 1.39/patient/year for 12- versus 1-month use of HFNC, respectively ( <0.001). The HFNC group had improved mMRC scores from 3 months onward ( <0.001) and improved SGRQ at 6 and 12 months ( =0.002, =0.033) and PaCO ( =0.005) and 6MWT ( =0.005) at 12 months. There was no difference in all-cause mortality. HFNC treatment reduced AECOPD, hospital admissions and symptoms in COPD patients with hypoxic failure.

Oxygen therapy prolongs survival in patients with severe hypoxemia but is a burden. In this trial, therapy for 24 rather than 15 hours per day did not reduce the risk of hospitalization or death at 1 year.

IntroductionFirst-line oxygenation strategy in patients with acute hypoxaemic respiratory failure consists in standard oxygen or high-flow nasal oxygen therapy. Clinical practice guidelines suggest the use of high-flow nasal oxygen rather than standard oxygen. However, findings remain contradictory with a low level of certainty. We hypothesise that compared with standard oxygen, high-flow nasal oxygen may reduce mortality in patients with acute hypoxaemic respiratory failure.Method and analysisThe Standard Oxygen versus High-flow nasal Oxygen-trial is an investigator-initiated, multicentre, open-label, randomised controlled trial comparing high-flow nasal oxygen versus standard oxygen in patients admitted to an intensive care unit (ICU) for acute respiratory failure with moderate-to-severe hypoxaemia. 1110 patients will be randomly assigned to one of the two groups with a ratio of 1:1. The primary outcome is the number of patients who died 28 days after randomisation. Secondary outcomes include comfort, dyspnoea and oxygenation 1 hour after treatment initiation, the number of patients intubated at day 28, mortality in ICU, in hospital and until day 90, and complications during ICU stay.Ethics and disseminationThe study has been approved by the central Ethics Committee ‘Sud Méditerranée III’ (2020-07-05) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04468126.

PurposeThe aim of this study was to evaluate one-year outcomes of lower versus higher oxygenation targets in intensive care unit (ICU) patients with coronavirus disease 2019 (COVID-19) and severe hypoxaemia.MethodsWe conducted pre-planned analyses of one-year mortality and health-related quality of life (HRQoL) in the Handling Oxygenation Targets in COVID-19 trial. The trial randomised 726 ICU patients with COVID-19 and hypoxaemia to partial pressure of arterial oxygen targets of 8 kPa (60 mmHg) versus 12 kPa (90 mmHg) during ICU stay up to 90 days, including readmissions. HRQoL was assessed using EuroQol visual analogue scale (EQ-VAS) and 5-level 5-dimension questionnaire (EQ-5D-5L). Outcomes were analysed in the intention-to-treat population. Non-survivors were assigned the worst possible score (zero), and multiple imputation was applied for missing EQ-VAS values.ResultsWe obtained one-year vital status for 691/726 (95.2%) of patients and HRQoL data for 642/726 (88.4%). At one year, 117/348 (33.6%) of patients in the lower-oxygenation group had died compared to 134/343 (39.1%) in the higher-oxygenation group (adjusted risk ratio: 0.85; 98.6% confidence interval (CI) 0.66–1.09; p = 0.11). Median EQ-VAS was 50 (interquartile range, 0–80) versus 40 (0–75) (adjusted mean difference: 4.8; 98.6% CI  − 2.2 to 11.9; p = 0.09) and EQ-5D-5L index values were 0.61 (0–0.81) in the lower-oxygenation group versus 0.43 (0–0.79) (p = 0.20) in the higher-oxygenation group, respectively.ConclusionAmong adult ICU patients with COVID-19 and severe hypoxaemia, one-year mortality results were most compatible with benefit of the lower oxygenation target, which did not appear to result in more survivors with poor quality of life.

In rural hospitals of developing countries, oxygen supplies are poor and detection of hypoxaemia is difficult. Oxygen concentrators and pulse oximeters might help to manage the disease; however, use of such technology in developing countries needs comprehensive assessment. We studied the effect of an improved oxygen system on death rate in children with pneumonia in Papua New Guinea. We installed an improved oxygen system in five hospitals in Papua New Guinea, and assessed its use in more than 11 000 children with pneumonia (2001–07) and compared case-fatality rates. Admissions between January, 2001, and December, 2004, formed the pre-intervention group, and those between July, 2005, and October, 2007, formed the post-intervention group. Oxygen concentrators and pulse oximeters were introduced in the five hospitals, and a protocol for detection of hypoxaemia and clinical use of oxygen was supplied. All children admitted had their oxygen saturation measured; if it was less than 90%, oxygen was delivered via nasal prongs at a starting flow rate of 0·5–1 L/min. We recorded all costs associated with the establishment and maintenance of this system. The study was approved by the Medical Research Advisory Committee of Papua New Guinea, number MRAC 04.02. Before the use of this system, 356 of 7161 children admitted in the five hospitals for pneumonia died (case-fatality rate 4·97% [95% CI 4·5–5·5]), whereas 133 of 4130 children died in the 27 months after the introduction of the system (3·22% [2·7–3·8]). After the improved system was introduced, the risk of death for a child with pneumonia was 35% lower than was that before the project began (risk ratio 0·65 [0·52–0·78], p<0·0001). Mortality rates varied between hospitals. The estimated costs of this system were US$51 per patient treated, US$1673 per life saved, and US$50 per disability-adjusted life-year (DALY) averted. Pulse oximetry and oxygen concentrators can alleviate oxygen shortages, reduce mortality, and improve quality of care for children with pneumonia in developing countries. The cost-effectiveness of this system compared favourably with that of other public-health interventions. The Papua New Guinea National Department of Health; WHO, Papua New Guinea and Western Pacific Regional Office; AirSep corporation, Buffalo, NY, USA; the Ross Trust, VIC, Australia; AusAID; Jacques Gostelli, Switzerland; and a grant from the University of Melbourne.

Background The impact of the permissive hypotension approach in clinically well infants on regional cerebral oxygen saturation (rScO 2 ) and autoregulatory capacity (CAR) remains unknown. Methods Prospective cohort study of blinded rScO 2 measurements within a randomized controlled trial of management of hypotension (HIP trial) in extremely preterm infants. rScO 2 , mean arterial blood pressure, duration of cerebral hypoxia, and transfer function (TF) gain inversely proportional to CAR, were compared between hypotensive infants randomized to receive dopamine or placebo and between hypotensive and non-hypotensive infants, and related to early intraventricular hemorrhage or death. Results In 89 potentially eligible HIP trial patients with rScO 2 measurements, the duration of cerebral hypoxia was significantly higher in 36 hypotensive compared to 53 non-hypotensive infants. In 29/36 hypotensive infants (mean GA 25 weeks, 69% males) receiving the study drug, no significant difference in rScO 2 was observed after dopamine ( n  = 13) compared to placebo ( n  = 16). Duration of cerebral hypoxia was associated with early intraventricular hemorrhage or death.  Calculated TF gain ( n  = 49/89) was significantly higher reflecting decreased CAR in 16 hypotensive compared to 33 non-hypotensive infants. Conclusions Dopamine had no effect on rScO 2 compared to placebo in hypotensive infants. Hypotension and cerebral hypoxia are associated with early intraventricular hemorrhage or death. Impact Treatment of hypotension with dopamine in extremely preterm infants increases mean arterial blood pressure, but does not improve cerebral oxygenation. Hypotensive extremely preterm infants have increased duration of cerebral hypoxia and reduced cerebral autoregulatory capacity compared to non-hypotensive infants. Duration of cerebral hypoxia and hypotension are associated with early intraventricular hemorrhage or death in extremely preterm infants. Since systematic treatment of hypotension may not be associated with better outcomes, the diagnosis of cerebral hypoxia in hypotensive extremely preterm infants might guide treatment.

Background Pneumonia is a leading cause of childhood mortality globally. Oxygen therapy improves survival in children with pneumonia, yet its availability remains limited in many resource-constrained settings where most deaths occur. Solar-powered oxygen delivery could be a sustainable method to improve oxygen delivery in remote areas with restricted access to a supply chain of compressed oxygen cylinders and reliable electrical power. Methods/Design This study is a randomized controlled trial (RCT). Solar-powered oxygen delivery systems will be compared to a conventional method (oxygen from cylinders) in patients with hypoxemic respiratory illness. Enrollment will occur at two sites in Uganda: Jinja Regional Referral Hospital and Kambuga District Hospital. The primary outcome will be the length of hospital stay. Secondary study endpoints will be mortality, duration of supplemental oxygen therapy (time to wean oxygen), proportion of patients successfully oxygenated, delivery system failure, cost, system maintenance and convenience. Discussion The RCT will provide useful data on the feasibility and noninferiority of solar-powered oxygen delivery. This technological innovation uses freely available inputs, the sun and the air, to oxygenate children with pneumonia, and can be applied “off the grid” in remote and/or resource-constrained settings where most pneumonia deaths occur. If proven successful, solar-powered oxygen delivery systems could be scaled up and widely implemented for impact on global child mortality. Trial registration Clinicaltrials.gov registration number NCT0210086 (date of registration: 27 March, 2014)

A prior report on hypothermia for neonatal hypoxic–ischemic encephalopathy showed a reduced rate of death or disability at 18 to 22 months of age. In this report of outcomes at 6 to 7 years, rates of death or an IQ below 70 were nonsignificantly lower with hypothermia than with usual care. Moderate or severe neonatal hypoxic–ischemic encephalopathy is associated with a high incidence of death or motor and sensory disability in children. 1 – 5 Children with encephalopathy are at risk for cognitive deficits even in the absence of functional deficits. Survivors without disability have delayed entry into primary school and fine-motor dysfunction and behavioral abnormalities. Hypothermia to 33 to 34°C for 72 hours, when initiated within 6 hours after birth among infants of more than 35 weeks' gestational age with hypoxic–ischemic encephalopathy, has been shown to reduce the risk of death or disability and increase the rate of survival free of disability . . .

Objective The objective of our study was to examine the relationship between brain injury and outcome following neonatal hypoxic–ischaemic encephalopathy treated with hypothermia. Design and patients Neonatal MRI scans were evaluated in the National Institute of Child Health and Human Development (NICHD) randomised controlled trial of whole-body hypothermia and each infant was categorised based upon the pattern of brain injury on the MRI findings. Brain injury patterns were assessed as a marker of death or disability at 18–22 months of age. Results Scans were obtained on 136 of 208 trial participants (65%); 73 in the hypothermia and 63 in the control group. Normal scans were noted in 38 of 73 infants (52%) in the hypothermia group and 22 of 63 infants (35%) in the control group. Infants in the hypothermia group had fewer areas of infarction (12%) compared to infants in the control group (22%). Fifty-one of the 136 infants died or had moderate or severe disability at 18 months. The brain injury pattern correlated with outcome of death or disability and with disability among survivors. Each point increase in the severity of the pattern of brain injury was independently associated with a twofold increase in the odds of death or disability. Conclusions Fewer areas of infarction and a trend towards more normal scans were noted in brain MRI following whole-body hypothermia. Presence of the NICHD pattern of brain injury is a marker of death or moderate or severe disability at 18–22 months following hypothermia for neonatal encephalopathy.

In this randomized trial involving newborn infants with asphyxial encephalopathy, hypothermic therapy did not significantly reduce the rate of the primary outcome (i.e., death or severe neurodevelopmental disability) but did result in improvement in several prespecified secondary neurologic outcomes among survivors. In newborn infants with asphyxial encephalopathy, hypothermic therapy did not significantly reduce the rate of the primary outcome (i.e., death or severe neurodevelopmental disability) but did result in improvement in several prespecified secondary neurologic outcomes among survivors. Perinatal asphyxial encephalopathy is associated with high morbidity and mortality rates worldwide and is a major burden for the patient, the family, and society. There is an urgent need to improve outcomes in affected infants. Experimentally, reducing body temperature to 3 to 5°C below the normal level reduces cerebral injury and improves neurologic function after asphyxia. 1 – 6 Preliminary clinical studies have found no serious adverse effects of cooling. 7 – 9 Two randomized, controlled trials, the CoolCap trial 10 and the National Institute of Child Health and Human Development (NICHD) trial, 11 have reported outcomes among infants at 18 months of age who had . . .