Erwan L'Her1,2, Samir Jaber3, Daniel Verzilli3, Christophe Jacob4, Brigitte Huiban4, Emmanuel Futier5, Thomas Kerforne6, Victoire Pateau2,7, Pierre-Alexandre Bouchard8, Maëlys Consigny9, François Lellouche8. 1. Medical Intensive Care, CHRU de Brest - La Cavale Blanche, Brest, France. 2. LATIM INSERM UMR 1101, FHU Techsan, Université de Bretagne Occidentale, Brest, France. 3. Intensive Care Unit, Dept of Anaesthesiology B, DAR B CHU de Montpellier, Hôpital Saint Eloi, Université Montpellier 1, Montpellier, France. 4. Anaesthesiology Dept, CHRU de Brest - La Cavale Blanche, Brest, France. 5. Anaesthesiology Dept, Hôpital Estaing, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France. 6. Anaesthesiology Dept, CHU de Poitiers, Cedex, France. 7. Oxynov Inc., Technopôle Brest Iroise, Plouzané, France. 8. Centre de recherche de l'Institut de Cardiologie et de Pneumologie de Québec, Quebec, Canada. 9. Centre d'Investigation Clinique CIC INSERM 1412, CHRU Brest - La Cavale Blanche, Brest, France.
Abstract
INTRODUCTION:Hypoxaemia and hyperoxaemia may occur after surgery, with related complications. This multicentre randomised trial evaluated the impact of automated closed-loop oxygen administration after high-risk abdominal or thoracic surgeries in terms of optimising the oxygen saturation measured by pulse oximetry time within target range. METHODS: After extubation, patients with an intermediate to high risk of post-operative 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% (95% CI -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% (95% CI 26.3-37.4%); p<0.0001). Periods of hypoxaemia were reduced in the automated group (≤3 days; 32.6±57.8 min (1.2±1.9%) versus 370.5±594.3 min (5.0±11.2%), difference -10.2% (95% CI -13.9--6.6%); p<0.0001), as well as hyperoxaemia under oxygen (≤3 days; 5.1±10.9 min (4.8±11.2%) versus 177.9±277.2 min (27.0±23.8%), difference -22.0% (95% CI -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. 25 patients experienced hypoxaemia for >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.
RCT Entities:
INTRODUCTION: Hypoxaemia and hyperoxaemia may occur after surgery, with related complications. This multicentre randomised trial evaluated the impact of automated closed-loop oxygen administration after high-risk abdominal or thoracic surgeries in terms of optimising the oxygen saturation measured by pulse oximetry time within target range. METHODS: After extubation, patients with an intermediate to high risk of post-operative 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% (95% CI -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% (95% CI 26.3-37.4%); p<0.0001). Periods of hypoxaemia were reduced in the automated group (≤3 days; 32.6±57.8 min (1.2±1.9%) versus 370.5±594.3 min (5.0±11.2%), difference -10.2% (95% CI -13.9--6.6%); p<0.0001), as well as hyperoxaemia under oxygen (≤3 days; 5.1±10.9 min (4.8±11.2%) versus 177.9±277.2 min (27.0±23.8%), difference -22.0% (95% CI -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. 25 patients experienced hypoxaemia for >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.
Authors: James C P Harper; Ruth Semprini; Nethmi A Kearns; Lee Hatter; Grace E Bird; Irene Braithwaite; Allie Eathorne; Mark Weatherall; Richard Beasley Journal: BMC Pulm Med Date: 2021-10-26 Impact factor: 3.317
Authors: Adrian Barnett; Richard Beasley; Catherine Buchan; Jimmy Chien; Claude S Farah; Gregory King; Christine F McDonald; Belinda Miller; Maitri Munsif; Alex Psirides; Lynette Reid; Mary Roberts; Natasha Smallwood; Sheree Smith Journal: Respirology Date: 2022-02-17 Impact factor: 6.175