Department of Anesthesia, Phu Tho General Hospital
Viet Tri, Phu Tho, 290000, Vietnam
Location status: Recruiting
NCT Number: NCT06879600
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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Request Info18 year and older
All sexes
Interventional
Not applicable
Viet Tri, Phu Tho, 290000, Vietnam
Location status: Recruiting
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:
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%.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Perioperative
PaO2 was checked via arterial blood gas at different time points
Time frame: Perioperative
SpO2 was recorded at baseline (before preoxygenation) and every 30 seconds during 3 minutes of preoxygenation
Time frame: Periprocedural
Desaturation is defined as SpO2 < 94% during apnea and intubation period of induction anesthesia
Time frame: Periprocedural
during apnea period, if SpO2 < 94% facemask ventilation will be applied
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
Time frame: Perioperative
Gastric volume assessment was accessed using ultrasound
Time frame: Periprocedural
regurgitation and aspiration were checked during laryngoscopy
Time frame: 1 hour after extubation
Evaluate after extubation
Time frame: During 3 minutes of preoxygenation
Any events of bradycardia, tachycardia, hypertension, or hypotension during preoxygenation period were recorded
Contact information is provided by the study sponsor or research team.
Nguyen Dang Thu
Other
Research on Pre-Anesthetic Blood Oxygenation Effect of High-Flow Nasal Oxygen for Emergency Surgery Patients With Full Stomachs
Acronym: HFNC
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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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