Fuller, G. orcid.org/0000-0001-8532-3500, Keating, S., Goodacre, S. orcid.org/0000-0003-0803-8444 et al. (12 more authors) (2020) Is a definitive trial of prehospital continuous positive airway pressure versus standard oxygen therapy for acute respiratory failure indicated? The ACUTE pilot randomised controlled trial. BMJ Open, 10 (7). e035915. ISSN 2044-6055
Abstract
Objectives To determine the feasibility of a large-scale definitive multicentre trial of prehospital continuous positive airway pressure (CPAP) in acute respiratory failure.
Design A single-centre, open-label, individual patient randomised, controlled, external pilot trial.
Setting A single UK Ambulance Service, between August 2017 and July 2018.
Participants Adults with respiratory distress and peripheral oxygen saturations below British Thoracic Society target levels despite controlled oxygen treatment.
Interventions Patients were randomised to prehospital CPAP (O-Two system) versus standard oxygen therapy in a 1:1 ratio using simple randomisation.
Primary and secondary outcome measures Feasibility outcomes comprised recruitment rate, adherence to allocated treatment, retention and data completeness. The primary clinical outcome was 30-day mortality.
Results 77 patients were enrolled (target 120), including 7 cases with a diagnosis where CPAP could be ineffective or harmful. CPAP was fully delivered in 74% (target 75%). There were no major protocol violations. Full data were available for all key outcomes (targets ≥90%). Overall 30-day mortality was 27.3%. Of these deceased patients, 14/21 (68%) either did not have a respiratory condition or had ceiling of treatment decisions implemented excluding hospital non-invasive ventilation and critical care.
Conclusions Recruitment rate was below target and feasibility was not demonstrated. Limited compliance with CPAP, and difficulty in identifying patients who could benefit from CPAP, indicate that prehospital CPAP is unlikely to materially reduce mortality. A definitive effectiveness trial of CPAP is therefore not recommended.
Trial registration number ISRCTN12048261; Post-results.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
Dates: |
|
Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research The University of Sheffield > Sheffield Teaching Hospitals |
Funding Information: | Funder Grant number NATIONAL INSTITUTE FOR HEALTH RESEARCH 15/08/40 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 27 Jul 2020 13:40 |
Last Modified: | 27 Jul 2020 17:05 |
Status: | Published |
Publisher: | BMJ |
Refereed: | Yes |
Identification Number: | 10.1136/bmjopen-2019-035915 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:163768 |