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Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study
INTRODUCTION: Hypoxemia and hyperoxia may occur after surgery with potential related complications. The FreeO(2) PostOp trial is a prospective, multicentre, randomised controlled trial that evaluates the clinical impact of automated O(2) administration versus conventional O(2) therapy after major ab...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340445/ https://www.ncbi.nlm.nih.gov/pubmed/30782716 http://dx.doi.org/10.1136/bmjopen-2018-023833 |
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author | L’her, Erwan Jaber, Samir Verzilli, Daniel Jacob, Christophe Huiban, Brigitte Futier, Emmanuel Kerforne, Thomas Pateau, Victoire Bouchard, Pierre-Alexandre Gouillou, Maellen Nowak, Emmanuel Lellouche, François |
author_facet | L’her, Erwan Jaber, Samir Verzilli, Daniel Jacob, Christophe Huiban, Brigitte Futier, Emmanuel Kerforne, Thomas Pateau, Victoire Bouchard, Pierre-Alexandre Gouillou, Maellen Nowak, Emmanuel Lellouche, François |
author_sort | L’her, Erwan |
collection | PubMed |
description | INTRODUCTION: Hypoxemia and hyperoxia may occur after surgery with potential related complications. The FreeO(2) PostOp trial is a prospective, multicentre, randomised controlled trial that evaluates the clinical impact of automated O(2) administration versus conventional O(2) therapy after major abdominal or thoracic surgeries. The study is powered to demonstrate benefits of automated oxygen titration and weaning in term of oxygenation, which is an important surrogate for complications after such interventions. METHODS AND ANALYSIS: After extubation, patients are randomly assigned to the Standard (manual O(2) administration) or FreeO(2) group (automated closed-loop O(2) administration). Stratification is performed for the study centre and a medical history of chronic obstructive pulmonary disease (COPD). Primary outcome is the percentage of time spent in the target zone of oxygen saturation, during a 3-day time frame. In both groups, patients will benefit from continuous oximetry recordings. The target zone of oxygen saturation is SpO(2)=88%–92% for patients with COPD and 92%–96% for patients without COPD. Secondary outcomes are the nursing workload assessed by the number of manual O(2) flow adjustments, the time spent with severe desaturation (SpO(2) <85%) and hyperoxia area (SpO(2) >98%), the time spent in a hyperoxia area (SpO(2) >98%), the VO(2), the duration of oxygen administration during hospitalisation, the frequency of use of mechanical ventilation (invasive or non-invasive), the duration of the postrecovery room stay, the hospitalisation length of stay and the survival rate. ETHICS AND DISSEMINATION: The FreeO(2) PostOp study is conducted in accordance with the declaration of Helsinki and was registered on 11 September 2015 (http://www.clinicaltrials.gov). First patient inclusion was performed on 14 January 2016. The results of the study will be presented at academic conferences and submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02546830. |
format | Online Article Text |
id | pubmed-6340445 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-63404452019-02-02 Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study L’her, Erwan Jaber, Samir Verzilli, Daniel Jacob, Christophe Huiban, Brigitte Futier, Emmanuel Kerforne, Thomas Pateau, Victoire Bouchard, Pierre-Alexandre Gouillou, Maellen Nowak, Emmanuel Lellouche, François BMJ Open Respiratory Medicine INTRODUCTION: Hypoxemia and hyperoxia may occur after surgery with potential related complications. The FreeO(2) PostOp trial is a prospective, multicentre, randomised controlled trial that evaluates the clinical impact of automated O(2) administration versus conventional O(2) therapy after major abdominal or thoracic surgeries. The study is powered to demonstrate benefits of automated oxygen titration and weaning in term of oxygenation, which is an important surrogate for complications after such interventions. METHODS AND ANALYSIS: After extubation, patients are randomly assigned to the Standard (manual O(2) administration) or FreeO(2) group (automated closed-loop O(2) administration). Stratification is performed for the study centre and a medical history of chronic obstructive pulmonary disease (COPD). Primary outcome is the percentage of time spent in the target zone of oxygen saturation, during a 3-day time frame. In both groups, patients will benefit from continuous oximetry recordings. The target zone of oxygen saturation is SpO(2)=88%–92% for patients with COPD and 92%–96% for patients without COPD. Secondary outcomes are the nursing workload assessed by the number of manual O(2) flow adjustments, the time spent with severe desaturation (SpO(2) <85%) and hyperoxia area (SpO(2) >98%), the time spent in a hyperoxia area (SpO(2) >98%), the VO(2), the duration of oxygen administration during hospitalisation, the frequency of use of mechanical ventilation (invasive or non-invasive), the duration of the postrecovery room stay, the hospitalisation length of stay and the survival rate. ETHICS AND DISSEMINATION: The FreeO(2) PostOp study is conducted in accordance with the declaration of Helsinki and was registered on 11 September 2015 (http://www.clinicaltrials.gov). First patient inclusion was performed on 14 January 2016. The results of the study will be presented at academic conferences and submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02546830. BMJ Publishing Group 2019-01-17 /pmc/articles/PMC6340445/ /pubmed/30782716 http://dx.doi.org/10.1136/bmjopen-2018-023833 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Respiratory Medicine L’her, Erwan Jaber, Samir Verzilli, Daniel Jacob, Christophe Huiban, Brigitte Futier, Emmanuel Kerforne, Thomas Pateau, Victoire Bouchard, Pierre-Alexandre Gouillou, Maellen Nowak, Emmanuel Lellouche, François Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study |
title | Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study |
title_full | Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study |
title_fullStr | Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study |
title_full_unstemmed | Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study |
title_short | Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study |
title_sort | automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study |
topic | Respiratory Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6340445/ https://www.ncbi.nlm.nih.gov/pubmed/30782716 http://dx.doi.org/10.1136/bmjopen-2018-023833 |
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