Comparing high flow nasal cannula to facial masks for chest trauma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of high flow nasal cannula (HFNC) compared to traditional facial masks in patients suffering from severe hypoxemia due to chest trauma. Conducted across three centers, the study will randomize eligible patients who are experiencing respiratory distress and have low arterial oxygen levels despite receiving standard oxygen therapy. The goal is to determine if HFNC can reduce the need for intubation in these patients within the first 72 hours after their injury.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.)

Exclusion Criteria:

1. Patients with a Glasgow Coma Scale less than 8 or severe brain injury.
2. Patients with any contraindications to non-invasive ventilation, including acute gastrointestinal bleeding, upper airway obstruction, or hemodynamic instability.
3. Facial trauma involving skull base fractures, facial bone fractures, or orbital floor fractures.
4. Severe injuries involving the nasal sinuses.
5. Patients with cervical spine injuries.
6. Patients with increased intracranial pressure.
7. Patients with facial, nasal, or airway structural abnormalities or surgery that prevents the use of appropriate nasal cannula.
8. Patients after upper airway surgery.
9. Patients who are unable to clearly express their willingness to sign informed consent.

Where it's running

• Department of Traumatology, National Taiwain University Hospital
  Taipei, Taipei, Taiwan Recruiting
• NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch
  Taipei, Taiwan, Taiwan Recruiting

Study contacts

• Principal investigator: Hsien-Chi Liao, MD — department of trauma of National University Hospital
• Study coordinator: Hsien-Chi Liao, MD
• Email: polarisliao@hotmail.com
• Phone: +886-972651611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.