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Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25° head-up position and supine: the InSize25 study protocol
  1. Anne-Sophie Falempin1,
  2. Bruno Pereira2,
  3. Fatima Binakdane3,
  4. Jean-Etienne Bazin4,
  5. Margot Smirdec5
  1. 1 Department of Perioperative Medicine, University Hospital–Clermont-Ferrand, Clermont-Ferrand Cedex 1, France
  2. 2 Biostatistics Unit of the Department of Clinical Research and Innovation (DRCI), University Hospital CHU Clermont-Ferrand, Clermont-Ferrand, France
  3. 3 Department of Anaesthesia and Surgery Critical Care, Saint-Louis Hospital, Assistance Publique–Hopitaux de Paris, Paris, France
  4. 4 Department of Perioperative Medicine, Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
  5. 5 University Hospital–Clermont-Ferrand, Clermont-Ferrand Cedex 1, France
  1. Correspondence to Dr Margot Smirdec; msmirdec{at}chu-clermontferrand.fr

Abstract

Introduction Difficult airway management during tracheal intubation can lead to severe hypoxic sequelae. Routine intubation practice is to use a strict supine position, whereas a 25° head-up or reverse Trendelenburg position increases efficacy of preoxygenation, seems more comfortable for the anaesthetist and may also provide better intubation conditions in direct laryngoscopy. The 25° head-up position could be used for the whole population rather than only for obese patients, but there is no prospective randomised controlled trial with a robust design and large number of patients comparing strict supine against 25° intubation in operating room. The objective of the InSize25 study is to test the effect of these two patient positions on intubation conditions during laryngoscopy in scheduled surgery on non-obese patients.

Methods and analysis InSize25 is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial. The InSize25 study will randomise 1000 adult patients scheduled for surgery under general anaesthesia requiring intubation with neuromuscular-blocking drugs, candidates for direct laryngoscopy. The primary outcome variable is the view obtained during the first laryngoscopy without any external manipulation assessed using percentage of glottic opening. Important secondary outcomes are: Cormack-Lehane classification, number of attempts at laryngoscopy and at tracheal intubation, use of ancillary equipment (eg, bougies, alternative laryngoscope blades, videolaryngoscope) and manoeuvres (eg, laryngeal manipulation), comfort score for the anaesthetist, episodes of postinduction hypotension or desaturation and mechanical complications of intubation.

Ethics and dissemination The trial received appropriate approval from the ‘CPP Sud-Est II’ ethical review board. Informed consent is required. If the 25° head-up position proves superior for tracheal intubation without more complications, it may become the routine-standard intubation position rather than only for use with obese patients. The final results will be published in a peer-reviewed journal.

Trial registration number Clinicaltrials.gov identifier (NCT03339141).

  • anaesthetics
  • intubation
  • laryngoscopy
  • glottis
  • view
  • 25° head-up position

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/.

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Footnotes

  • Twitter @Fatima BINAKDANE

  • Contributors MS takes responsibility for the content of the manuscript. MS, BP and J-EB were involved in the conception, hypotheses delineation and design of the study, acquisition and analysis of the data, in writing the article and in its revision prior to submission. A-SF and FB were involved in the design of the study, acquisition and analysis of the data, in writing the article and in its revision prior to submission.

  • Funding This study received support from University Hospital—–Clermont-Ferrand.

  • Disclaimer The funders have no influence on the study design, conduct and analysis or in the preparation of this article.

  • Competing interests The study is an investigator-initiated trial. The study is sponsored by Clermont-Ferrand University Hospital, Clermont-Ferrand, France. There is no industry support or involvement in the trial. The principal investigators have no financial or other competing interests.

  • Patient consent for publication Obtained.

  • Ethics approval The Insize25 study is conducted in accordance with the Declaration of Helsinki and was registered at http://www.clinicaltrial.gov on 13 November 2017 under trial identification number NCT03339141. The trial received appropriate approval from the ‘CPP Sud-Est II’ ethical review board in October 2017 (ID-RCB: 2016-A02078-43). Any change to eligibility criteria, outcomes and analyses will be notified to the investigators and ethics committee to secure prior approval.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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