scholarly journals A feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients

2021 ◽  
pp. 175114372110100
Author(s):  
Daniel S Martin ◽  
Margaret McNeil ◽  
Chris Brew-Graves ◽  
Helder Filipe ◽  
Ronan O’Driscoll ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Group Versus ◽  
Weighted Average ◽  
Control Group ◽  
Mechanically Ventilated ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Background Despite oxygen being the commonest drug administered to critically ill patients we do not know which oxygen saturation (SpO2) target results in optimal survival outcomes in those receiving mechanical ventilation. We therefore conducted a feasibility randomised controlled trial in the United Kingdom (UK) to assess whether it would be possible to host a larger national multi-centre trial to evaluate oxygenation targets in mechanically ventilated patients. Methods We set out to recruit 60 participants across two sites into a trial in which they were randomised to receive conservative oxygenation (SpO2 88–92%) or usual care (control – SpO2 ≥96%). The primary outcome was feasibility; factors related to safety and clinical outcomes were also assessed. Results A total of 34 patients were recruited into the study until it was stopped due to time constraints. A number of key barriers to success were identified during the course of the study. The conservative oxygenation intervention was feasible and appeared to be safe in this small patient cohort and it achieved wide separation of the median time-weighted average (IQR) SpO2 at 91% (90–92%) in conservative oxygenation group versus 97% (96–97%) in control group. Conclusion Whilst conservative oxygenation was a feasible and safe intervention which achieved clear group separation in oxygenation levels, the model used in this trial will require alterations to improve future participant recruitment rates in the UK.

scholarly journals Protocol for a feasibility randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021674 ◽  
Author(s):  
Daniel S Martin ◽  
Chris Brew-Graves ◽  
Neil McCartan ◽  
Gavin Jell ◽  
Ingrid Potyka ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Critical Care ◽  
Randomised Controlled Trial ◽  
Critically Ill ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Mechanically Ventilated ◽  
Systemic Oxidative Stress ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

IntroductionOxygen is the most commonly administered drug to mechanically ventilated critically ill adults, yet little is known about the optimum oxygen saturation (SpO2) target for these patients; the current standard of care is an SpO2of 96% or above. Small pilot studies have demonstrated that permissive hypoxaemia (aiming for a lower SpO2than normal by using a lower fractional inspired oxygen concentration (FIO2)) can be achieved in the critically ill and appears to be safe. This approach has not been evaluated in a National Health Service setting. It is possible that permissive hypoxaemia may be beneficial to critically ill patients thus it requires robust evaluation.Methods and analysisTargeted OXygen therapY in Critical illness (TOXYC) is a feasibility randomised controlled trial (RCT) to evaluate whether recruiting patients to a study of permissive hypoxaemia is possible in the UK. It will also investigate biological mechanisms that may underlie the links between oxygenation and patient outcomes. Mechanically ventilated patients with respiratory failure will be recruited from critical care units at two sites and randomised (1:1 ratio) to an SpO2target of either 88%–92% or ≥96% while intubated with an endotracheal tube. Clinical teams can adjust FIO2and ventilator settings as they wish to achieve these targets. Clinical information will be collected before, during and after the intervention and blood samples taken to measure markers of systemic oxidative stress. The primary outcome of this study is feasibility, which will be assessed by recruitment rate, protocol adherence and withdrawal rates. Secondary outcomes will include a comparison of standard critical care outcome measures between the two intervention groups, and the measurement of biomarkers of systemic oxidative stress. The results will be used to calculate a sample size, likely number of sites and overall length of time required for a subsequent large multicentre RCT.Ethics and disseminationThis study was approved by the London - Harrow Research Ethics Committee on 2 November 2017 (REC Reference 17/LO/1334) and received HRA approval on 13 November 2017. Results from this study will be disseminated in peer-reviewed journals, at medical and scientific meetings, in the NIHR Journals Library and patient information websites.Trial registration numberNCT03287466; Pre-results.

Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial

The Lancet ◽  
2009 ◽  
Vol 373 (9678) ◽  
pp. 1874-1882 ◽  
Author(s):  
William D Schweickert ◽  
Mark C Pohlman ◽  
Anne S Pohlman ◽  
Celerina Nigos ◽  
Amy J Pawlik ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Occupational Therapy ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Controlled Trial ◽  
Mechanically Ventilated ◽  
Randomised Controlled
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