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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06879600
Acronym
HFNC
Enrollment
200
Registered
2025-03-17
Start date
2023-07-19
Completion date
2026-12-31
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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%.

Interventions

DEVICEHigh-flow nasal cannula therapy application

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

DEVICETraditional facemask

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.

Sponsors

Hanoi Medical University
CollaboratorOTHER
Phu Tho General Hospital
CollaboratorUNKNOWN
Nguyen Dang Thu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

prospective, single-center, randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PaO2PerioperativePaO2 was checked via arterial blood gas at different time points
Changes SpO2 during 3 minutes of preoxygenationPerioperativeSpO2 was recorded at baseline (before preoxygenation) and every 30 seconds during 3 minutes of preoxygenation
Incidence of desaturation during rapid sequence induction anesthesiaPeriproceduralDesaturation is defined as SpO2 \< 94% during apnea and intubation period of induction anesthesia
Number of episode of facemask ventilation during apnea periodPeriproceduralduring apnea period, if SpO2 \< 94% facemask ventilation will be applied

Secondary

MeasureTime frameDescription
Changes TcCO2PeriproceduralContinuous 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
Hemodynamic effectsDuring 3 minutes of preoxygenationAny events of bradycardia, tachycardia, hypertension, or hypotension during preoxygenation period were recorded
Gastric volumePerioperativeGastric volume assessment was accessed using ultrasound
Incidence of regurgitation and aspirationPeriproceduralregurgitation and aspiration were checked during laryngoscopy
Nasal congestion1 hour after extubationEvaluate after extubation

Countries

Vietnam

Contacts

Primary ContactHong Bui Minh, M.D
Drhong88gmhs@gmail.com0971025586

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026