High-Flow Nasal Oxygen for Preoxygenation in Emergency Surgery Patients With Full Stomachs

NCT06879600 | Recruiting

• 2 other identifiers: HongGMHS-No.1185NCS42HFNC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with full stomachs face a high risk of regurgitation and aspiration under general anesthesia. To minimize the time between the loss of airway protective reflexes and successful tracheal intubation, rapid sequence induction intubation is commonly used. However, these patients are particularly vulnerable to hypoxemia during anesthesia induction, especially in emergency cases. Pre-oxygenation before induction is crucial for ensuring patient safety during apnea. High-flow nasal oxygen (HFNO) therapy, which consists of an air/oxygen blender, an active humidifier, and a single heated circuit, has recently gained widespread use in intensive care units (ICUs) for managing hypoxemic respiratory failure. HFNC can deliver a constant fraction of inspired oxygen (FiO₂) from 0.21 to 1.0 at high flow rates (up to 60 L/min or higher). Its advantages include generating continuous positive airway pressure, reducing anatomical dead space, improving ventilation-perfusion matching, enhancing mucociliary clearance, and decreasing the work of breathing. Given these benefits, HFNO has the potential to improve pre-oxygenation before and during anesthesia induction in emergency surgery patients with full stomachs.

Conditions

High-flow Nasal Cannula; Oxygenation; General Anesthesia; Induction Anesthesia; Emergency Surgery Patients; Full Stomach

Keywords

High-flow nasal cannula; oxygenation; Induction anesthesia; Emergency Surgery Patients; full stomach

Outcome Measures

Primary Outcomes (4)

• PaO2

  PaO2 was checked via arterial blood gas at different time points

  Perioperative

• Changes SpO2 during 3 minutes of preoxygenation

  SpO2 was recorded at baseline (before preoxygenation) and every 30 seconds during 3 minutes of preoxygenation

  Perioperative

• Incidence of desaturation during rapid sequence induction anesthesia

  Desaturation is defined as SpO2 \< 94% during apnea and intubation period of induction anesthesia

  Periprocedural

• Number of episode of facemask ventilation during apnea period

  during apnea period, if SpO2 \< 94% facemask ventilation will be applied

  Periprocedural

Secondary Outcomes (5)

• Changes TcCO2

  Periprocedural

• Gastric volume

  Perioperative

• Incidence of regurgitation and aspiration

  Periprocedural

• Nasal congestion

  1 hour after extubation

• Hemodynamic effects

  During 3 minutes of preoxygenation

Study Arms (2)

High-flow nasal cannula therapy application

ACTIVE COMPARATOR

Intervention Group: Patients will undergo HFNC preoxygenation for 3 minutes with a flow rate of 60 L/min of heated and humidified pure oxygen (100% FiO₂, 37°C - Optiflow; Fisher \& Paykel Healthcare, Auckland, New Zealand). To minimize air contamination, large or medium nasal cannulae will be selected based on the patient's nostril size. During the intubation process, HFNC will be maintained to facilitate either: Continuous oxygenation while the patient breathes spontaneously, or Apneic oxygenation during laryngoscopy for rapid sequence intubation (RSI).

Device: High-flow nasal cannula therapy application

Traditional facemask

PLACEBO COMPARATOR

Control Group: Patients will undergo preoxygenation for 3 minutes using a face mask (sized appropriately to fit the patient and ensure an airtight seal) connected to an Aisys CS2 ventilation system (General Electric, GE Healthcare, Oy, Finland). In this group, the ventilation system will be set with a fresh gas flow of 10 L/min, FiO₂ = 100%, without inspiratory support or expiratory positive pressure. The face mask (Economy, Intersurgical, Fontenay-sous-Bois, France) will be removed after induction to enable intubation.

Device: Traditional facemask

Interventions

High-flow nasal cannula therapy application DEVICE

Patients will undergo HFNC preoxygenation for 3 minutes with a flow rate of 60 L/min of heated and humidified pure oxygen (100% FiO₂, 37°C - Optiflow; Fisher \& Paykel Healthcare, Auckland, New Zealand). To minimize air contamination, large or medium nasal cannulae will be selected based on the patient's nostril size

High-flow nasal cannula therapy application

Traditional facemask DEVICE

Patients will undergo preoxygenation for 3 minutes using a face mask (sized appropriately to fit the patient and ensure an airtight seal) connected to an Aisys CS2 ventilation system (General Electric, GE Healthcare, Oy, Finland). In this group, the ventilation system will be set with a fresh gas flow of 10 L/min, FiO₂ = 100%, without inspiratory support or expiratory positive pressure. The face mask (Economy, Intersurgical, Fontenay-sous-Bois, France) will be removed after induction to enable intubation.

Traditional facemask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency surgical patients at risk of gastric fullness requiring endotracheal intubation.
• Patients aged 18 years or older.
• Health status classified as ASA I or II.
• Mallampati classification I or II.

You may not qualify if:

• Patients with a predicted difficult airway, facial deformities, or an inability to achieve a proper mask seal.
• Patients with respiratory diseases.
• Pregnant patients.
• Patients allergic to anesthesia or resuscitation drugs.
• Patients who do not consent to participate in the study.

Sponsors & Collaborators

• Nguyen Dang Thu: lead
• Hanoi Medical University: collaborator
• Phu Tho General Hospital: collaborator

Study Sites (1)

Department of Anesthesia, Phu Tho General Hospital

Việt Trì, Phu Tho, 290000, Vietnam

RECRUITING

Related Publications (6)

• Vargas F, Saint-Leger M, Boyer A, Bui NH, Hilbert G. Physiologic Effects of High-Flow Nasal Cannula Oxygen in Critical Care Subjects. Respir Care. 2015 Oct;60(10):1369-76. doi: 10.4187/respcare.03814. Epub 2015 May 5.

  PMID: 25944940 BACKGROUND

• Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

  PMID: 25869405 BACKGROUND

• Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.

  PMID: 25388828 BACKGROUND

• Badiger S, John M, Fearnley RA, Ahmad I. Optimizing oxygenation and intubation conditions during awake fibre-optic intubation using a high-flow nasal oxygen-delivery system. Br J Anaesth. 2015 Oct;115(4):629-32. doi: 10.1093/bja/aev262. Epub 2015 Aug 7.

  PMID: 26253608 BACKGROUND

• Lodenius A, Piehl J, Ostlund A, Ullman J, Jonsson Fagerlund M. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) vs. facemask breathing pre-oxygenation for rapid sequence induction in adults: a prospective randomised non-blinded clinical trial. Anaesthesia. 2018 May;73(5):564-571. doi: 10.1111/anae.14215. Epub 2018 Jan 13.

  PMID: 29330853 BACKGROUND

• Lam ND, Son LDT, Phat TM, Thu ND, Nga NT, Son VT, Hong BM. High-flow nasal oxygen versus face-mask ventilation for rapid sequence induction in non-elective surgical patients: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 31. doi: 10.1186/s12871-026-03654-w. Online ahead of print.

  PMID: 41620676 DERIVED

Study Officials

• Lam Nguyen Duc, Assoc.Prof, PhD, MD

  Hanoi Medical University

  STUDY DIRECTOR

Central Study Contacts

Hong Bui Minh, M.D

CONTACT

0971025586; Drhong88gmhs@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D; M.D.

Model Details: prospective, single-center, randomized controlled trial

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 17, 2025
• Study Start: July 19, 2023
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)