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Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study

Erwan L'Her, Samir Jaber, Daniel Verzilli, Christophe Jacob, Brigitte Huiban, Emmanuel Futier, Thomas Kerforne, Victoire Pateau, Pierre-Alexandre Bouchard, Maëlys Consigny, François Lellouche
European Respiratory Journal 2020; DOI: 10.1183/13993003.00182-2020
Erwan L'Her
1Medical Intensive Care, CHRU de Brest - La Cavale Blanche, Brest Cedex, France
2LATIM INSERM UMR 1101, FHU Techsan, Université de Bretagne Occidentale, Brest, France
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  • ORCID record for Erwan L'Her
  • For correspondence: Erwan.lher@chu-brest.fr
Samir Jaber
3Intensive Care Unit, Department of Anaesthesiology B, DAR B CHU de Montpellier, Hôpital Saint Eloi, Université Montpellier 1, Montpellier, France
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Daniel Verzilli
3Intensive Care Unit, Department of Anaesthesiology B, DAR B CHU de Montpellier, Hôpital Saint Eloi, Université Montpellier 1, Montpellier, France
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Christophe Jacob
4Anaesthesiology Department, CHRU de Brest - La Cavale Blanche, Bvd Tanguy-Prigent, Brest Cedex, France
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Brigitte Huiban
4Anaesthesiology Department, CHRU de Brest - La Cavale Blanche, Bvd Tanguy-Prigent, Brest Cedex, France
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Emmanuel Futier
5Anaesthesiology Department, Hôpital Estaing, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France
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Thomas Kerforne
6Anaesthesiology Department, CHU de Poitiers, Cedex, France
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Victoire Pateau
2LATIM INSERM UMR 1101, FHU Techsan, Université de Bretagne Occidentale, Brest, France
7Oxynov Inc., Technopôle Brest Iroise, Plouzané, France
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Pierre-Alexandre Bouchard
8Centre de recherche de l'Institut de Cardiologie et de Pneumologie de Québec, Québec, Canada
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Maëlys Consigny
9Centre d'Investigation Clinique CIC INSERM 1412, CHRU Brest - La Cavale Blanche, Brest Cedex, France
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François Lellouche
8Centre de recherche de l'Institut de Cardiologie et de Pneumologie de Québec, Québec, Canada
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Abstract

Introduction Hypoxaemia and hyperoxaemia may occur after surgery, with related complications. This multicentre and randomised trial evaluated the impact of automated closed-loop oxygen administration after high-risk abdominal or thoracic surgeries in terms of optimising the SpO2 time within target range.

Methods After extubation, patients with an intermediate to high risk for postoperative pulmonary complications were randomised to Standard or Automated closed-loop oxygen administration. The primary outcome was the percentage of time within the oxygenation range, during a 3-day frame. The secondary outcomes were the time with hypoxaemia and hyperoxaemia under oxygen.

Results Among the 200 patients, time within range was higher in the Automated group, both initially (≤3-h; 91.4±13.7 versus 40.2±35.1% of time; difference +51.0% [CI95% −42.8;59.2]; p<0.0001) and during the 3-day period (94.0±11.3 versus 62.1±23.3% of time; difference +31.9% [CI95% 26.3;37.4]; p<0.0001). Periods of hypoxaemia were reduced in the Automated group (≤3 days; 32.6±57.8 [1.2±1.9%] versus 370.5±594.3 min [5.0±11.2%]; difference −10.2% [CI95% −13.9;-6.6]; p<0.0001), as well as hyperoxaemia under oxygen (≤3 days; 5.1±10.9 [4.8±11.2%] versus 177.9±277.2 min [27.0±23.8%]; difference −22.0% [CI95% −27.6;-16.4]; p<0.0001). Kaplan-Meier analysis depicted a significant difference in terms of hypoxaemia (p=0.01) and severe hypoxaemia (p=0.0003) occurrence between groups in favour of the Automated group. Twenty-five patients experienced hypoxaemia for more than 10% of the entire monitoring time during the 3 days within the Standard group, as compared to the Automated group (p<0.0001).

Conclusion Automated closed-loop oxygen administration promotes greater time within the oxygenation target, as compared to Standard manual administration, thus reducing the occurrence of hypoxaemia and hyperoxaemia.

Footnotes

This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.

Conflict of interest: Dr. L'Her reports other from OXYNOV, during the conduct of the study; personal fees from Smiths Medical, personal fees and other from GE Healthcare, grants and personal fees from Sedana Medical, outside the submitted work; In addition, Dr. L'Her has a patent Method and device for delivering oxygen licensed to Oxynov.

Conflict of interest: Dr. JABER reports personal fees from Drager, personal fees from Fisher-Paykel, personal fees from Baxter, personal fees from Fresenius-Xenios, personal fees from Medtronic, during the conduct of the study;.

Conflict of interest: Dr. VERZILLI has nothing to disclose.

Conflict of interest: Dr. JACOB has nothing to disclose.

Conflict of interest: Dr. HUIBAN has nothing to disclose.

Conflict of interest: Dr. FUTIER reports consulting fees from DRAGER MEDICAL, consulting fees from GE HEALTHCARE, consulting fees from ORION PHARMA, consulting fees from EDWARDS LIFESCIENCES, lecture fees from FRESENIUS KABI, lecture fees from GETINGE, non-financial support from FISHER AND PAYKEL HEALTHCARE, during the conduct of the study;.

Conflict of interest: Dr. KERFORNE has nothing to disclose.

Conflict of interest: Dr. Pateau reports other from OxyNov, during the conduct of the study;.

Conflict of interest: Dr. Bouchard has nothing to disclose.

Conflict of interest: Dr. Consigny has nothing to disclose.

Conflict of interest: Dr. Lellouche reports other from Oxynov, during the conduct of the study;.

This is a PDF-only article. Please click on the PDF link above to read it.

  • Received January 30, 2020.
  • Accepted July 17, 2020.
  • Copyright ©ERS 2020
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Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study
Erwan L'Her, Samir Jaber, Daniel Verzilli, Christophe Jacob, Brigitte Huiban, Emmanuel Futier, Thomas Kerforne, Victoire Pateau, Pierre-Alexandre Bouchard, Maëlys Consigny, François Lellouche
European Respiratory Journal Jan 2020, 2000182; DOI: 10.1183/13993003.00182-2020

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Automated closed-loop versus standard manual oxygen administration after major abdominal or thoracic surgery: an international multicentre randomised controlled study
Erwan L'Her, Samir Jaber, Daniel Verzilli, Christophe Jacob, Brigitte Huiban, Emmanuel Futier, Thomas Kerforne, Victoire Pateau, Pierre-Alexandre Bouchard, Maëlys Consigny, François Lellouche
European Respiratory Journal Jan 2020, 2000182; DOI: 10.1183/13993003.00182-2020
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