Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial

Mui Teng Chua, Faheem Ahmed Khan, Wei Ming Ng, Qingshu Lu, Matthew Jian Wen Low, Ying Wei Yau, Amila Punyadasa, Win Sen Kuan, Mui Teng Chua, Faheem Ahmed Khan, Wei Ming Ng, Qingshu Lu, Matthew Jian Wen Low, Ying Wei Yau, Amila Punyadasa, Win Sen Kuan

Abstract

Background: Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or a prolonged vegetative state requiring long-term institutionalisation. Despite employing current best practices during RSI, desaturation during intubation still occurs. High-flow nasal cannula (HFNC) oxygenation may potentially improve oxygenation during pre- and apnoeic oxygenation to allow a longer safe apnoeic time for RSI.

Objective: We aim to test the hypothesis that the use of humidified high-flow oxygenation via nasal cannula at 60 L/min maintains higher oxygen saturation compared with current usual care of non-rebreather mask and standard nasal cannula at an oxygen flow rate of 15 L/min for pre- and apnoeic oxygenation.

Methods: This is a multi-centre randomised controlled trial enrolling adult patients aged 21 years and older who require rapid sequence intubation due to medical, surgical, or traumatic conditions in the Emergency Departments (EDs) of the National University Hospital and the Ng Teng Fong General Hospital. Eligible patients will undergo randomisation at an equal ratio into intervention or control arms. The primary endpoint will be the lowest oxygen saturation achieved during the first intubation attempt from time of administration of paralytic agent until quantitative end-tidal carbon dioxide is detected if the first intubation attempt is successful, or until the start of the second attempt if it is not.

Discussion: Prolongation of safe apnoea time through maintenance of oxygen saturation above 90% using HFNC oxygenation during RSI could potentially change current clinical practice, improve standard of care, and translate to better outcomes for patients.

Trial registration: ClinicalTrials.gov, NCT03396094 . Registered on 10 January 2018.

Keywords: Apnoeic oxygenation; High flow nasal oxygenation; Pre-oxygenation; Rapid sequence intubation.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval for waiver of consent at time of enrolment and delayed informed consent was obtained from the National Healthcare Group’s (NHG) Domain Specific Review Board (DSRB reference number 2017/00348).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Randomisation flow chart. *Usual care for pre-oxygenation involves the use of non-rebreather mask. RSI rapid sequence intubation, SpO2 saturation of peripheral oxygen
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram. ARDS acute respiratory distress syndrome, CXR chest x-ray, EM emergency medicine, HFNC high-flow nasal cannula, ICU intensive care unit, NP nasal prongs, NRM non-rebreather mask, SOFA Sequential Organ Failure Assessment, SpO2 saturation of peripheral oxygen

References

    1. Walls RM, Brown CA, Bair AE, et al. Emergency airway management: a multi-center report of 8937 Emergency Department intubations. J Emerg Med. 2011;41:347–354. doi: 10.1016/j.jemermed.2010.02.024.
    1. Thorpe CM, Gauntlett IS. Arterial oxygen saturation during induction of anaesthesia. Anaesthesia. 1990;45:1012–1015. doi: 10.1111/j.1365-2044.1990.tb14876.x.
    1. Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012;59:165–175. doi: 10.1016/j.annemergmed.2011.10.002.
    1. Goh LG, Pang J. Obesity in Singapore, prevention and control. SFP. 2012;38:8–13.
    1. Wyatt SB, Winters KP, Dubbert PM. Overweight and obesity: prevalence, consequences, and causes of a growing public health problem. Am J Med Sci. 2006;331:166–174. doi: 10.1097/00000441-200604000-00002.
    1. Benumof JL, Dagg R, Benumof R. Critical hemoglobin desaturation will occur before return to unparalyzed state from 1 mg/kg succinylcholine. Anesthesiology. 1997;87:979–982. doi: 10.1097/00000542-199710000-00034.
    1. Sakles JC, Chiu S, Mosier J, et al. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013;20:71–78. doi: 10.1111/acem.12055.
    1. Hasegawa K, Shigemitsu K, Hagiwara Y, et al. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012;60:749–754. doi: 10.1016/j.annemergmed.2012.04.005.
    1. Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004;99:607–613. doi: 10.1213/01.ANE.0000122825.04923.15.
    1. Munn MW. The legislative framework governing clinical trials in Singapore. . Accessed 23 May 2018.
    1. Wood L, Egger M, Jüni P, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336:601–605. doi: 10.1136/.
    1. Pruitt W, Jacobs M. Breathing lessons: basics of oxygen therapy. Nursing. 2003;33:43–45. doi: 10.1097/00152193-200310000-00044.
    1. Baraka AS, Taha SK, Aouad MT, et al. Preoxygenation: comparison of maximal breathing and tidal volume breathing techniques. Anaesthesiology. 1999;91:612–616. doi: 10.1097/00000542-199909000-00009.
    1. Hamilton WK, Eastwood DW. A study of denitrogenation with some inhalation anesthetic systems. Anaesthesiology. 1955;16:861–867. doi: 10.1097/00000542-195511000-00004.
    1. Walls RM, Murphy MF. Manual of emergency airway management. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2012.
    1. Vourc’h M, Asfar P, Volteau C, et al. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015;41:1538–48.
    1. Miguel-Montanes R, Hajage D, Messika J, et al. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015;43:574–583. doi: 10.1097/CCM.0000000000000743.
    1. Baillard C, Fosse J-P, Sebbane M, et al. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006;174:171–177. doi: 10.1164/rccm.200509-1507OC.
    1. Ramkumar V, Philip FA. Preoxygenation with 20 degrees head-up tilt provides longer duration of non-hypoxic apnea than conventional preoxygenation in non-obese healthy adults. J Anesth. 2011;25:189. doi: 10.1007/s00540-011-1098-3.
    1. Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015;3:15.
    1. Parke RL, McGuinness SP, Eccleston ML. A preliminary randomized controlled trial to assess effectiveness of nasal high-flow oxygen in intensive care patients. Respir Care. 2011;56:265–270. doi: 10.4187/respcare.00801.
    1. Semler MW, Janz DR, Lentz RJ, et al. Randomized trial of apneic oxygenation during endotracheal intubation of the critically ill. Am J Respir Crit Care Med. 2016;193:273–280. doi: 10.1164/rccm.201507-1294OC.
    1. Ritchie JE, Williams AB, Hockey H. Evaluation of a humidified nasal high flow oxygen system, using oxygraphy, capnography, and measurement of upper airway pressures. Anaesth Intensive Care. 2011;39:1103–1110. doi: 10.1177/0310057X1103900620.
    1. Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012;109:i68–i85. doi: 10.1093/bja/aes393.
    1. Woodall N, Frerk C, Cook TM. Can we make airway management (even) safer? Lessons from national audit. Anaesthesia. 2011;66:27–33. doi: 10.1111/j.1365-2044.2011.06931.x.
    1. Cook TM, Benger J. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011;106:632–642. doi: 10.1093/bja/aer059.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren