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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNguyen Dang Thu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: High-flow nasal cannula therapy applicationActive comparator 1 intervention
Group B: Traditional facemaskPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

PaO2

PaO2 was checked via arterial blood gas at different time points

Time frame
Perioperative
2

Changes SpO2 during 3 minutes of preoxygenation

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

Time frame
Perioperative
3

Incidence of desaturation during rapid sequence induction anesthesia

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

Time frame
Periprocedural
4

Number of episode of facemask ventilation during apnea period

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

Time frame
Periprocedural

Secondary outcomes

1

Changes TcCO2

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

Time frame
Periprocedural
2

Gastric volume

Gastric volume assessment was accessed using ultrasound

Time frame
Perioperative
3

Incidence of regurgitation and aspiration

regurgitation and aspiration were checked during laryngoscopy

Time frame
Periprocedural
4

Nasal congestion

Evaluate after extubation

Time frame
1 hour after extubation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nguyen Dang Thu

Lead sponsor

Vietnam Military Medical University

Sponsor institution

Hanoi Medical University

Collaborator

Phu Tho General Hospital

Collaborator