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A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory

Une étude randomisée contrôlée sur l’utilisation peropératoire de la ventilation non invasive par rapport à la supplémentation en oxygène par masque facial pour la sédation procédurale dans un laboratoire d’électrophysiologie

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Abstract

Purpose

The efficacy of noninvasive ventilation (NIV) during procedures that require sedation and analgesia has not been established. We evaluated whether NIV reduces the incidence of respiratory events.

Methods

In this randomized controlled trial, we included 195 patients with an American Society of Anesthesiologists Physical Status of III or IV during electrophysiology laboratory procedures. We compared NIV with face mask oxygen therapy for patients under sedation. The primary outcome was the incidence of respiratory events determined by a computer-driven blinded analysis and defined by hypoxemia (peripheral oxygen saturation < 90%) or apnea/hypopnea (absence of breathing for 20 sec on capnography). Secondary outcomes included hemodynamic variables, sedation, patient safety (composite scores of major or minor adverse events), and adverse outcomes at day 7.

Results

A respiratory event occurred in 89/98 (95%) patients in the NIV group and in 69/97 (73%) patients with face masks (risk ratio [RR], 1.29; 95% confidence interval [CI], 1.13 to 1.47; P < 0.001). Hypoxemia occurred in 40 (42%) patients in the NIV group and in 33 (34%) patients with face masks (RR, 1.21; 95% CI, 0.84 to 1.74; P = 0.30). Apnea/hypopnea occurred in 83 patients (92%) in the NIV group vs 65 patients (70%) with face masks (RR, 1.32; 95% CI, 1.14 to 1.53; P < 0.001). Hemodynamic variables, sedation, major or minor safety events, and patient outcomes were not different between the groups.

Conclusions

Respiratory events were more frequent among patients receiving NIV without any safety or outcome impairment. These results do not support the routine use of NIV intraoperatively.

Study registration

ClinicalTrials.gov (NCT02779998); registered 4 November 2015.

Résumé

Objectif

L’efficacité de la ventilation non invasive (VNI) pendant les interventions nécessitant une sédation et une analgésie n’a pas été établie. Nous avons évalué si la VNI réduisait l’incidence des complications respiratoires.

Méthode

Dans cette étude randomisée contrôlée, nous avons inclus 195 patient·es de statut physique III ou IV selon l’American Society of Anesthesiologists pendant des interventions en laboratoire d’électrophysiologie. Nous avons comparé la VNI à l’oxygénothérapie par masque facial pour les patient·es sous sédation. Le critère d’évaluation principal était l’incidence des complications respiratoires déterminée par une analyse en aveugle assistée par ordinateur et définie par une hypoxémie (saturation périphérique en oxygène < 90 %) ou une apnée/hypopnée (absence de respiration pendant 20 secondes à la capnographie). Les critères d’évaluation secondaires comprenaient les variables hémodynamiques, la sédation, la sécurité des patient·es (scores composites des événements indésirables majeurs ou mineurs) et les issues indésirables au jour 7.

Résultats

Un événement respiratoire est survenu chez 89/98 (95 %) patient·es du groupe VNI et chez 69/97 (73 %) patient·es ayant un masque facial (risque relatif [RR], 1,29; intervalle de confiance [IC] à 95 %, 1,13 à 1,47; P < 0,001). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21 ; IC à 95 %, 0,84 à 1,74; P = 0,30). Une hypoxémie est survenue chez 40 (42 %) patient·es du groupe VNI et chez 33 (34 %) patient·es ayant un masque facial (RR, 1,21; IC 95 %, 0,84 à 1,74; P = 0,30). Les variables hémodynamiques, la sédation, les événements de sécurité majeurs ou mineurs et les issues pour les patient·es n’étaient pas différents entre les groupes.

Conclusion

Les complications respiratoires étaient plus fréquentes chez les patient·es recevant une VNI sans aucun impact sur la sécurité ou les issues. Ces résultats n’appuient pas l’utilisation systématique de la VNI en peropératoire.

Enregistrement de l’étude

ClinicalTrials.gov (NCT02779998); enregistrée le 4 novembre 2015.

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Author contributions

Pierre-Henri Moury, Flora Greco, and Pierre Albaladejo designed the study; Pierre-Henri Moury, Valentin Pasquier, Flora Greco, Jean-Lionel Arvieux, Silvia Alves-Macedo, Marion Richard, and Myriam Casez-Brasseur enrolled the patients; Pierre-Henri Moury, Jean-Lionel Arvieux, Silvia Alves-Macedo, Damien Bedague, Michel Durand, and Marion Richard conducted the study; Kristina Skaare and Jean-Luc Bosson analyzed the data; Pierre-Henri Moury, Valentin Pasquier, Jean-Luc Bosson, and Pierre Albaladejo analyzed all the data; Pierre-Henri Moury and Valentin Pasquier interpreted the results; Pierre-Henri Moury and Valentin Pasquier drafted the manuscript; all authors had full access to all of the study data, contributed to drafting of the manuscript or critically revised it for important intellectual content, and took responsibility for the integrity of the data and the accuracy of the data analysis.

Acknowledgements

The authors would like to thank l’école d’infirmier anesthésiste of the CHU Grenoble Alpes, the nurse anesthetists, the anesthetists, and the intensivists of the cardiovascular and thoracic unit. The authors would like to thank the neurosurgery anesthesia and intensive care unit teams for their involvement and independent assessment in the blinded analysis: Drs Perrine Boucheix, Lara Puthon, Marie-Cécile Fèvre, and Clotilde Schilte.

Disclosures

There are no conflicts of interest to disclose related to the subject of the article.

Funding statement

This study was supported by an institutional grant from CHU Grenoble Alpes. The foundation Agiradom provided masks and the respirator. Alpha2® (Lyon, France) provided the CO2 analysis.

Prior conference presentations

The abstract of the article was accepted for presentation at the 2020 congress of the Société Française d'Anesthésie-Réanimation (24–26 Spetember 2020, Paris, France).

Editorial responsibility

This submission was handled by Dr. Philip M. Jones, Deputy Editor-in-Chief, Canadian Journal of Anesthesia/Journal canadien d’anesthésie.

Author information

Authors and Affiliations

  1. Pôle Anesthésie-Réanimation, CHU Grenoble Alpes, Grenoble, France

    Valentin Pasquier MD, Flora Greco MD, Jean-Lionel Arvieux MSc, Silvia Alves-Macedo MSc, Marion Richard MSc, Myriam Casez-Brasseur MD, Michel Durand MD, Damien Bedague MD & Pierre Albaladejo MD, PhD

  2. HP2 Laboratory, U1042, Grenoble Alpes University, Grenoble, France

    Pierre-Henri Moury MD, MSc

  3. Department of Biostatistics, Public Health, ThEMAS, Université Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France

    Kristina Skaare MSc & Jean-Luc Bosson MD, PhD

  4. Department of Cardiology, CHU Grenoble Alpes, Grenoble, France

    Peggy Jacon MD

  5. Intensive Care Unit, Anesthesiology and Critical Care Department B, Saint Eloi Teaching Hospital, Université Montpellier 1, Centre Hospitalier Universitaire Montpellier, Montpellier, France

    Samir Jaber MD, PhD

  6. Pôle Anesthésie-Réanimation, Réanimation Cardiovasculaire et Thoracique, CHU Grenoble Alpes, CS 10217, Grenoble Cedex 9, France

    Pierre-Henri Moury MD, MSc

Authors
  1. Pierre-Henri Moury MD, MSc
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Correspondence to Pierre-Henri Moury MD, MSc.

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Moury, PH., Pasquier, V., Greco, F. et al. A randomized controlled trial of the intraoperative use of noninvasive ventilation versus supplemental oxygen by face mask for procedural sedation in an electrophysiology laboratory. Can J Anesth/J Can Anesth 70, 1182–1193 (2023). https://doi.org/10.1007/s12630-023-02495-2

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