High-flow Nasal CannulaHFNCNCT06879600
High-Flow Nasal Oxygen for Preoxygenation in Emergency Surgery Patients With Full Stomachs
A study testing High-flow nasal cannula therapy application and Traditional facemask in people with High-flow Nasal Cannula and Oxygenation, run by Nguyen Dang Thu at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-flow Nasal Cannula, Oxygenation, General Anesthesia
- What is being tested?
- High-flow nasal cannula therapy application and Traditional facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteVietnam
- Study dates
- 19 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Department of Anesthesia, Phu Tho General Hospital
Viet Tri, Phu Tho, 290000
Phat Tran Minh, M.D, 0975531647, Tranminhphat01091966@gmail.com
About this study
Official title: Research on Pre-Anesthetic Blood Oxygenation Effect of High-Flow Nasal Oxygen for 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.
Read the 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%.
- Conditions
- High-flow Nasal Cannula, Oxygenation, General Anesthesia, Induction Anesthesia, Emergency Surgery Patients, Full Stomach
- Being tested
- High-flow nasal cannula therapy application, Traditional facemask
- Keywords
- High-flow nasal cannula, oxygenation, Induction anesthesia, Emergency Surgery Patients, full stomach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal cannula therapy applicationDevice
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 facemaskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: High-flow nasal cannula therapy application |
| 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. Receives: Device: Traditional facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2
PaO2 was checked via arterial blood gas at different time points
Measured: Perioperative
Changes SpO2 during 3 minutes of preoxygenation
SpO2 was recorded at baseline (before preoxygenation) and every 30 seconds during 3 minutes of preoxygenation
Measured: Perioperative
Incidence of desaturation during rapid sequence induction anesthesia
Desaturation is defined as SpO2 < 94% during apnea and intubation period of induction anesthesia
Measured: Periprocedural
Number of episode of facemask ventilation during apnea period
during apnea period, if SpO2 < 94% facemask ventilation will be applied
Measured: Periprocedural
Secondary outcomes (5)
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
Measured: Periprocedural
Gastric volume
Gastric volume assessment was accessed using ultrasound
Measured: Perioperative
Incidence of regurgitation and aspiration
regurgitation and aspiration were checked during laryngoscopy
Measured: Periprocedural
Nasal congestion
Evaluate after extubation
Measured: 1 hour after extubation
Hemodynamic effects
Any events of bradycardia, tachycardia, hypertension, or hypotension during preoxygenation period were recorded
Measured: During 3 minutes of preoxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start19 Jul 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for High-flow Nasal CannulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, single-center, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nguyen Dang Thu
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University, Phu Tho General Hospital
- Responsible party
- Sponsor-investigator, Nguyen Dang Thu, Vietnam Military Medical University
- Investigators
- Lam Nguyen Duc, Assoc.Prof, PhD, MD, Study director, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879600
- Sponsor's protocol ID
- HongGMHS-No.1185
- Other IDs
- NCS42HFNC
- Acronym
- HFNC
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25944940Vourc'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.
PubMed 25869405Patel 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.
PubMed 25388828Badiger 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.
PubMed 26253608Lodenius 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.
PubMed 29330853Lam 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.
PubMed 41620676
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Pre-Anesthetic Blood Oxygenation Effect of High-Flow Nasal Oxygen for Emergency Surgery Patients With Full Stomachs
- ClinicalTrials.gov ID
- NCT06879600
- Acronym / sponsor ID
- HFNC / HongGMHS-No.1185
- Conditions
- High-flow Nasal Cannula, Oxygenation, General Anesthesia, Induction Anesthesia, Emergency Surgery Patients, Full Stomach
- Keywords
- High-flow nasal cannula, oxygenation, Induction anesthesia, Emergency Surgery Patients, full stomach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nguyen Dang ThuUniversity, hospital or other
- Collaborators
- Hanoi Medical University, Phu Tho General Hospital
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, single-center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula therapy application | Active comparator | Device: High-flow nasal cannula therapy applicationIntervention 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 | Device: Traditional facemaskControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow nasal cannula therapy applicationPatients 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 | Device | High-flow nasal cannula therapy application |
| Traditional facemaskPatients 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. | Device | Traditional facemask |
Primary outcome
PaO2
Time frame: Perioperative
PaO2 was checked via arterial blood gas at different time points
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
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
Number of episode of facemask ventilation during apnea period
Time frame: Periprocedural
during apnea period, if SpO2 < 94% facemask ventilation will be applied
5 secondary outcomes
Changes TcCO2
Time frame: Periprocedural
Gastric volume
Time frame: Perioperative
Incidence of regurgitation and aspiration
Time frame: Periprocedural
Nasal congestion
Time frame: 1 hour after extubation
Hemodynamic effects
Time frame: During 3 minutes of preoxygenation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 25944940Vargas 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.
- Background: PubMed 25869405Vourc'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.
- Background: PubMed 25388828Patel 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.
- Background: PubMed 26253608Badiger 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.
- Background: PubMed 29330853Lodenius 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.
- Derived from this study: PubMed 41620676Lam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lam Nguyen Duc, Assoc.Prof, PhD, MD study director
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal cannula therapy application and Traditional facemask in people with High-flow Nasal Cannula and Oxygenation, run by Nguyen Dang Thu at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Bui Minh, M.D (0971025586, Drhong88gmhs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2 (time frame: Perioperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879600, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.