Chest TraumaNCT05828030
HFNC Compared With Facial Mask in Patients With Chest Trauma Patients
A study testing high flow nasal cannula and Oxygen mask in people with Chest Trauma and Hypoxia, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Guidelines for noninvasive ventilation (NIV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic . However, no any suggestion was applied for high flow nasal cannula (HFNC). Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Chest Trauma, Hypoxia
- What is being tested?
- high flow nasal cannula and Oxygen mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- 26 Apr 2023to 31 Dec 2027
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have the following condition within 72 hours of chest trauma despite receiving standard nasal cannula oxygen therapy [≥10 L/min], are eligible for inclusion.
- severe hypoxemic respiratory failure [Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen fraction(FiO2) <300 mmHg]
- with a respiratory rate >25 breaths/minute and difficulty breathing, or respiratory distress
- PaCO2 of 45 mmHg or higher (if the patient requires emergency surgery with endotracheal intubation and mechanical ventilation, the time of inclusion will be the start of the post-extubation period. (Note: For patients who receive emergency trauma surgery with endotracheal intubation and mechanical ventilation, the time of inclusion assessment will be 72 hours after extubation.)
Who cannot join
- Patients with a Glasgow Coma Scale less than 8 or severe brain injury.
- Patients with any contraindications to non-invasive ventilation, including acute gastrointestinal bleeding, upper airway obstruction, or hemodynamic instability.
- Facial trauma involving skull base fractures, facial bone fractures, or orbital floor fractures.
- Severe injuries involving the nasal sinuses.
- Patients with cervical spine injuries.
- Patients with increased intracranial pressure.
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- Patients with facial, nasal, or airway structural abnormalities or surgery that prevents the use of appropriate nasal cannula.
- Patients after upper airway surgery.
- Patients who are unable to clearly express their willingness to sign informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Department of Traumatology, National Taiwain University Hospital
Taipei, Taipei, 10002
Hsien-Chi Liao, M.D., 886-2-23123456 ext. 51611, polarisliao@hotmail.com
- Recruiting
NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch
Taipei, Taiwan, 100; 300; 640; 280
Pei-Hsing Chen, MD, +886-972653530, b96401034@ntu.edu.tw
Pei-Hsing Chen, MD
About this study
Official title: Noninvasive Ventilation With High Flow Nasal Cannula Compared With Facial Mask in Patients With Chest Trauma: a Randomized Controlled Study
Guidelines for noninvasive ventilation (NIV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic . However, no any suggestion was applied for high flow nasal cannula (HFNC). Therefore, Our aim was to determine whether HFNC reduces intubation in severe trauma-related hypoxemia.
Read the detailed description
This would be a three-center randomized clinical trial of a level I trauma hospital. Inclusion criteria were patients with Arterial oxygen level (Pao2/)fraction of inspired oxygen inspired oxygen fraction(Fio2)<300 while receiving oxygen by high-flow mask within the first 72 h after thoracic trauma. Patients were randomized to remain on high-flow oxygen mask/ noninvasive ventilation or to receive HFNC. The interface was selected based on the associated injuries.
- Conditions
- Chest Trauma, Hypoxia
- Being tested
- high flow nasal cannula, Oxygen mask
- Medical subject headings
- Thoracic Injuries, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaProcedure or surgery
the patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
Oxygen maskProcedure or surgery
All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal cannula group | Experimental | All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at titrated from 60 L/min. Receives: Procedure: high flow nasal cannula |
| Oxygen Mask group | Active comparator | All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. Receives: Procedure: Oxygen mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of event of intubation or pneumonia
Intubation criteria included a respiratory rate of >40 breaths per minute, signs of increased breathing effort, SpO2 of <90% despite high fraction of inspired oxygen inspired oxygen fraction or acidosis with the quantitative measure of the acidity or basicity of aqueous or other liquid solutions (pH scale) of <7.35, occurrence of hemodynamic instability or deterioration of neurologic status.
Measured: 30 days after randomization
Secondary outcomes (2)
P/F ratio
P/F ratio would be count at the time 0/4/12/24/48 hours after randomization
Measured: 48 hrs after randomization
pneumonia rate /tracheostomy rate
diagnosis of pneumonia was determined according to radiologic evidence of new or progressive infiltrate of more than 48 hours and laboratory detection of a causative agent.
The management and diagnosis of all patients was performed by a trauma specialist.
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start26 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsien-Chi Liao, MD, Principal investigator, department of trauma of National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828030
- Sponsor's protocol ID
- 202211029DIND
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ventilation With High Flow Nasal Cannula Compared With Facial Mask in Patients With Chest Trauma: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05828030
- Acronym / sponsor ID
- 202211029DIND
- Conditions
- Chest Trauma, Hypoxia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Apr 2023 (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.
Guidelines for noninvasive ventilation (NIV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic . However, no any suggestion was applied for high flow nasal cannula (HFNC). Therefore, Our aim was to determine whether HFNC reduces intubation in severe trauma-related hypoxemia.
Detailed description
This would be a three-center randomized clinical trial of a level I trauma hospital. Inclusion criteria were patients with Arterial oxygen level (Pao2/)fraction of inspired oxygen inspired oxygen fraction(Fio2)<300 while receiving oxygen by high-flow mask within the first 72 h after thoracic trauma. Patients were randomized to remain on high-flow oxygen mask/ noninvasive ventilation or to receive HFNC. The interface was selected based on the associated injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal cannula group | Experimental | Procedure: high flow nasal cannulaAll patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at titrated from 60 L/min. |
| Oxygen Mask group | Active comparator | Procedure: Oxygen maskAll patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have the following condition within 72 hours of chest trauma despite receiving standard nasal cannula oxygen therapy [≥10 L/min], are eligible for inclusion.
- severe hypoxemic respiratory failure [Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen fraction(FiO2) <300 mmHg]
- with a respiratory rate >25 breaths/minute and difficulty breathing, or respiratory distress
- PaCO2 of 45 mmHg or higher (if the patient requires emergency surgery with endotracheal intubation and mechanical ventilation, the time of inclusion will be the start of the post-extubation period. (Note: For patients who receive emergency trauma surgery with endotracheal intubation and mechanical ventilation, the time of inclusion assessment will be 72 hours after extubation.)
Key exclusion criteria (9 listed)
- Patients with a Glasgow Coma Scale less than 8 or severe brain injury.
- Patients with any contraindications to non-invasive ventilation, including acute gastrointestinal bleeding, upper airway obstruction, or hemodynamic instability.
- Facial trauma involving skull base fractures, facial bone fractures, or orbital floor fractures.
- Severe injuries involving the nasal sinuses.
- Patients with cervical spine injuries.
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 cannulathe patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. | Procedure or surgery | high flow nasal cannula group |
| Oxygen maskAll patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. | Procedure or surgery | Oxygen Mask group |
Primary outcome
Rate of event of intubation or pneumonia
Time frame: 30 days after randomization
Intubation criteria included a respiratory rate of >40 breaths per minute, signs of increased breathing effort, SpO2 of <90% despite high fraction of inspired oxygen inspired oxygen fraction or acidosis with the quantitative measure of the acidity or basicity of aqueous or other liquid solutions (pH scale) of <7.35, occurrence of hemodynamic instability or deterioration of neurologic status.
2 secondary outcomes
P/F ratio
Time frame: 48 hrs after randomization
pneumonia rate /tracheostomy rate
Time frame: 30 days after randomization
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 8 Sep 2025.
- 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.
Hsien-Chi Liao, MD principal investigator
department of trauma of National University Hospital
2 sites 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 and Oxygen mask in people with Chest Trauma and Hypoxia, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 9 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. 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 Hsien-Chi Liao, MD (+886-972651611, polarisliao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of event of intubation or pneumonia (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.