Fuller, G, Keating, S, Goodacre, S, Herbert, E, Perkins, G, Rosser, A, Gunson, I, Miller, J, Ward, M, Bradburn, M, Thokala, P, Harris, T, Marsh, M, Scott, AJ ORCID: https://orcid.org/0000-0001-7426-7099 and Cooper, C (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 - ?.

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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.

Item Type: Article
Additional Information: 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/.
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
Divisions: Faculty of Natural Sciences > School of Psychology
Related URLs:
Depositing User: Symplectic
Date Deposited: 15 Feb 2021 16:27
Last Modified: 18 Mar 2021 11:55
URI: https://eprints.keele.ac.uk/id/eprint/9154

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