Clinical trial NCT06879600: High-Flow Nasal Oxygen for Preoxygenation in Emergency Surgery Patients With Full Stomachs
Official title: Research on Pre-Anesthetic Blood Oxygenation Effect of High-Flow Nasal Oxygen for Emergency Surgery Patients With Full Stomachs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Vietnam Military Medical University
Sponsor class: OTHER
Collaborators: name: Hanoi Medical University
name: Phu Tho General Hospital
First posted: 2025-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-center, randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, single-center, randomized controlled trial designed to evaluate the effects of HFNO on preoxygenation before and during anesthesia induction in emergency surgery patients with full stomachs. Adult patients undergoing emergency surgery with general anesthesia will be enrolled in the study.

After obtaining written informed consent, patients will be randomly assigned to one of the study groups:

- Intervention Group: Patients will undergo HFNO 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, HFNO will be maintained to facilitate either: Continuous oxygenation while the patient breathes spontaneously, or Apneic oxygenation during laryngoscopy for rapid sequence intubation (RSI).

- 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.

Rapid sequence induction and intubation were performed using fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (1 mg/kg). Intubation was performed 90 seconds after rocuronium administration. Cricoid pressure was applied from the moment the patient lost consciousness until intubation was successfully completed.

The current guidelines advise interrupting intubation to focus on oxygenation (ie, face mask ventilation) for oxygen desaturation ≤94%.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PaO2
timeFrame: Perioperative
measure: Changes SpO2 during 3 minutes of preoxygenation
timeFrame: Perioperative
measure: Incidence of desaturation during rapid sequence induction anesthesia
timeFrame: Periprocedural
measure: Number of episode of facemask ventilation during apnea period
timeFrame: Periprocedural
Secondary outcomes:
measure: Changes TcCO2
timeFrame: Periprocedural
measure: Gastric volume
timeFrame: Perioperative
measure: Incidence of regurgitation and aspiration
timeFrame: Periprocedural
measure: Nasal congestion
timeFrame: 1 hour after extubation
measure: Hemodynamic effects
timeFrame: During 3 minutes of preoxygenation
Other outcomes:
Locations:
city: Viet Tri
country: Vietnam
facility: Department of Anesthesia, Phu Tho General Hospital
state: Phu Tho
Study officials:
affiliation: Hanoi Medical University
name: Lam Nguyen Duc, Assoc.Prof, PhD, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.