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| ID | Type | Description | Link |
|---|---|---|---|
| NCS42HFNC | Other Identifier | Hanoi Medical University |
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| Name | Class |
|---|---|
| Hanoi Medical University | OTHER |
| Phu Tho General Hospital | UNKNOWN |
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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal cannula therapy application | Active Comparator | Intervention Group: 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. During the intubation process, HFNC will be maintained to facilitate either: Continuous oxygenation while the patient breathes spontaneously, or Apneic oxygenation during laryngoscopy for rapid sequence intubation (RSI). |
|
| Traditional facemask | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2 | PaO2 was checked via arterial blood gas at different time points | Perioperative |
| Changes SpO2 during 3 minutes of preoxygenation | SpO2 was recorded at baseline (before preoxygenation) and every 30 seconds during 3 minutes of preoxygenation | Perioperative |
| Incidence of desaturation during rapid sequence induction anesthesia | Desaturation is defined as SpO2 < 94% during apnea and intubation period of induction anesthesia | Periprocedural |
| Number of episode of facemask ventilation during apnea period | during apnea period, if SpO2 < 94% facemask ventilation will be applied | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Periprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Bui Minh, M.D | Contact | 0971025586 | Drhong88gmhs@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lam Nguyen Duc, Assoc.Prof, PhD, MD | Hanoi Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Phu Tho General Hospital | Recruiting | Viet Tri | Phu Tho | 290000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25944940 | Background | 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. | |
| 25869405 | Background | 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. |
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prospective, single-center, randomized controlled trial
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|
| 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. |
|
| Gastric volume | Gastric volume assessment was accessed using ultrasound | Perioperative |
| Incidence of regurgitation and aspiration | regurgitation and aspiration were checked during laryngoscopy | Periprocedural |
| Nasal congestion | Evaluate after extubation | 1 hour after extubation |
| Hemodynamic effects | Any events of bradycardia, tachycardia, hypertension, or hypotension during preoxygenation period were recorded | During 3 minutes of preoxygenation |
| 25388828 | Background | 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. |
| 26253608 | Background | 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. |
| 29330853 | Background | 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. |
| 41620676 | Derived | Lam ND, Son LDT, Phat TM, Thu ND, Nga NT, Son VT, Hong BM. High-flow nasal oxygen versus face-mask ventilation for rapid sequence induction in non-elective surgical patients: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 31;26(1):149. doi: 10.1186/s12871-026-03654-w. |