Comparison of preoxygenation with a high-flow nasal cannula and a simple mask before intubation during induction of general anesthesia in patients undergoing head and neck surgery: Study protocol clinical trial (SPIRIT Compliant)

Jun-Young Jo, Wook-Jong Kim, Seungwoo Ku, Seong-Soo Choi, Jun-Young Jo, Wook-Jong Kim, Seungwoo Ku, Seong-Soo Choi

Abstract

Background: To assess the arterial oxygen partial pressure (PaO2) at defined time points during preoxygenation and to compare high-flow heated humidified nasal oxygenation with standard preoxygenation using oxygen insufflation via a facemask for at least 5 minutes, before intubation during induction of general anesthesia.

Methods: This randomized, single-blinded, prospective study will be conducted in patients undergoing head and neck surgery. After standard monitoring, the artery catheter at the radial artery or dorsalis pedis artery will be placed and arterial blood gas analysis (ABGA) for baseline values will be performed simultaneously. Each group will be subjected to 1 of 2 preoxygenation methods (high-flow nasal cannula or simple facemask) for 5 minutes, and ABGA will be performed twice. After confirming intubation, we will start mechanical ventilation and check the vital signs and perform the final ABGA.

Discussion: This trial aims to examine the trajectory of PaO2 levels during the whole preoxygenation procedure and after intubation. We hypothesize that preoxygenation with the high-flow nasal cannula will be superior to that with the face mask.

Study registration: This trial was registered with the Clinical Trial Registry (NCT03896906; ClinicalTrials.gov).

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flow diagram of the study, ∗Data: arterial systolic, diastolic, and mean blood pressure, heart rate, and SpO2, T0 = pre-induction baseline, T3 = at second tidal volume, under mechanical ventilation after intubation, ABGA = arterial blood gas analysis, SpO2 = oxygen saturation, T1 = 2 minutes after preoxygenation, T2 = 5 minutes after preoxygenation.

References

    1. Frat JP, Ricard JD, Quenot JP, et al. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med 2019;7:303–12.
    1. Lumb AB, Thomas CR. High-flow nasal therapy: modelling the mechanism. Anaesthesia 2019;74:420–3.
    1. Shippam W, Preston R, Douglas J, et al. High-flow nasal oxygen vs. standard flow-rate facemask pre-oxygenation in pregnant patients: a randomised physiological study. Anaesthesia 2019;74:450–6.
    1. Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: physiologic basis, benefits, and potential risks. Anesth Analg 2017;124:507–17.
    1. Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol 2015;81:910–20.
    1. Gustafsson IM, Lodenius A, Tunelli J, et al. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological study. Br J Anaesth 2017;118:610–7.
    1. Booth AWG, Vidhani K, Lee PK, et al. SponTaneous Respiration using IntraVEnous anaesthesia and Hi-flow nasal oxygen (STRIVE Hi) maintains oxygenation and airway patency during management of the obstructed airway: an observational study. Br J Anaesth 2017;118:444–51.
    1. Pillai A, Daga V, Lewis J, et al. High-flow humidified nasal oxygenation vs. standard face mask oxygenation. Anaesthesia 2016;71:1280–3.
    1. Heinrich S, Horbach T, Stubner B, et al. Benefits of heated and humidified high flow nasal oxygen for preoxygenation in morbidly obese patients undergoing bariatric surgery: a randomized controlled study. J Obes Bariatrics 2014;1:7.
    1. Mir F, Patel A, Iqbal R, et al. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia 2017;72:439–43.
    1. Hermez LA, Spence CJ, Payton MJ, et al. A physiological study to determine the mechanism of carbon dioxide clearance during apnoea when using transnasal humidified rapid insufflation ventilatory exchange (THRIVE). Anaesthesia 2019;74:441–9.
    1. Barjaktarevic I, Esquinas AM, Johannes J, et al. Preoxygenation with high-flow nasal cannula: benefits of its extended use during the process of intubation. Respir Care 2017;62:390.
    1. Kim HJ, Asai T. High-flow nasal oxygenation for anesthetic management, Korean J Anesthesiol 2019;72:527–47.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
    1. Detsky ME, Jivraj N, Adhikari NK, et al. Will This Patient Be Difficult to Intubate? The Rational Clinical Examination Systematic Review. JAMA 2019;321:493–503.
    1. Luo D, Wan X, Liu J, et al. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res 2018;27:1785–805.
    1. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996;276:637–9.

Source: PubMed

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