TY - JOUR

T1 - Automated versus manual oxygen administration for patients admitted with acute cardiovascular disease - a study protocol of a randomised controlled trial

AU - Taraldsen, Ida Arentz

AU - Grand, Johannes

AU - Lukoschewitz, Jasmin Dam

AU - Hansen, Ejvind Frausing

AU - Hove, Jens Dahlgaard

N1 - Articles published in the DMJ are “open access”. This means that the articles are distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits any non-commercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

PY - 2023

Y1 - 2023

N2 - INTRODUCTION: Oxygen treatment of hypoxaemia is considered an essential part of the treatment of patients who are acutely admitted with medical conditions affecting cardiovascular and/or pulmonary function. Despite the important role of oxygen administration for these patients, clinical evidence on how to control supplemental oxygen to avoid hypoxaemia and hyperoxia is limited. We aim to investigate whether an automatic closed-loop oxygen administration system (O2matic) may maintain normoxaemia better than usual care.METHODS: This study will be an investigator-initiated, prospective, randomised clinical trial. The patients are randomised during admission after informed consent is obtained, at a 1:1 ratio with conventional oxygen treatment or O2matic oxygen treatment for 24 hours. The primary outcome is time within the desired peripheral capillary oxygen saturation interval: 92-96%.CONCLUSION: This study will examine the clinical applicability of a novel automated feedback device termed O2matic and assess whether the device is superior to standard care in keeping the patients in the optimal saturation interval. We hypothesise that the O2matic will increase time within the desired saturation interval.FUNDING: Johannes Grand's salary during this project is supported by a research grant from the Danish Cardiovascular Academy funded by Novo Nordisk Foundation grant number NNF20SA0067242 and by The Danish Heart Foundation.CLINICALTRIALS: gov (ClinicalTrials.gov Identifier: NCT05452863). Registered on 11 July 2022.

AB - INTRODUCTION: Oxygen treatment of hypoxaemia is considered an essential part of the treatment of patients who are acutely admitted with medical conditions affecting cardiovascular and/or pulmonary function. Despite the important role of oxygen administration for these patients, clinical evidence on how to control supplemental oxygen to avoid hypoxaemia and hyperoxia is limited. We aim to investigate whether an automatic closed-loop oxygen administration system (O2matic) may maintain normoxaemia better than usual care.METHODS: This study will be an investigator-initiated, prospective, randomised clinical trial. The patients are randomised during admission after informed consent is obtained, at a 1:1 ratio with conventional oxygen treatment or O2matic oxygen treatment for 24 hours. The primary outcome is time within the desired peripheral capillary oxygen saturation interval: 92-96%.CONCLUSION: This study will examine the clinical applicability of a novel automated feedback device termed O2matic and assess whether the device is superior to standard care in keeping the patients in the optimal saturation interval. We hypothesise that the O2matic will increase time within the desired saturation interval.FUNDING: Johannes Grand's salary during this project is supported by a research grant from the Danish Cardiovascular Academy funded by Novo Nordisk Foundation grant number NNF20SA0067242 and by The Danish Heart Foundation.CLINICALTRIALS: gov (ClinicalTrials.gov Identifier: NCT05452863). Registered on 11 July 2022.

KW - Humans

KW - COVID-19

KW - SARS-CoV-2

KW - Cardiovascular Diseases/therapy

KW - Prospective Studies

KW - Hypoxia/therapy

KW - Oxygen

KW - Treatment Outcome

KW - Randomized Controlled Trials as Topic

M3 - Journal article

C2 - 36999819

VL - 70

JO - Danish Medical Journal

JF - Danish Medical Journal

SN - 2245-1919

IS - 4

M1 - A12220784

ER -