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NCT Number: NCT06879600

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Phu Tho General Hospital

Viet Tri, Phu Tho, 290000, Vietnam

Location status: Recruiting

Location contact

Phat Tran Minh, M.D

CONTACT

[email protected]

0975531647

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. PaO2

    Time frame: Perioperative

    PaO2 was checked via arterial blood gas at different time points

  2. Changes SpO2 during 3 minutes of preoxygenation

    Time frame: Perioperative

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

  3. Incidence of desaturation during rapid sequence induction anesthesia

    Time frame: Periprocedural

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

  4. Number of episode of facemask ventilation during apnea period

    Time frame: Periprocedural

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

Secondary outcomes

  1. Changes TcCO2

    Time frame: Periprocedural

    Continuous transcutaneous CO2 partial pressure monitoring (TcCO2). TcCO2 was monitored with a sensor (V-Sign™ 2 sensor; SenTec, Switzerland) attached to the skin of the forearm or anterior chest, connected to the SenTec digital display after calibration. TcCO2 was recorded every 30 seconds during preoxygenation, apnea and intubation period

  2. Gastric volume

    Time frame: Perioperative

    Gastric volume assessment was accessed using ultrasound

  3. Incidence of regurgitation and aspiration

    Time frame: Periprocedural

    regurgitation and aspiration were checked during laryngoscopy

  4. Nasal congestion

    Time frame: 1 hour after extubation

    Evaluate after extubation

  5. Hemodynamic effects

    Time frame: During 3 minutes of preoxygenation

    Any events of bradycardia, tachycardia, hypertension, or hypotension during preoxygenation period were recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Bui Minh, M.D

CONTACT

[email protected]

0971025586

Sponsors and collaborators

Lead sponsor

Nguyen Dang Thu

Other

Collaborators

  • Hanoi Medical University
  • Phu Tho General Hospital

Registry information

Official study title

Research on Pre-Anesthetic Blood Oxygenation Effect of High-Flow Nasal Oxygen for Emergency Surgery Patients With Full Stomachs

Acronym: HFNC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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