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

Noninvasive Ventilation With High Flow Nasal Cannula Compared With Facial Mask in Patients With Chest Trauma: a Randomized Controlled Study

This study is testing if high flow nasal cannulas can help chest trauma patients breathe better and avoid needing a breathing tube compared to regular facial masks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 20 Years to 99 Years
• Sex: All
• Sponsor: National Taiwan University Hospital (other)
• Locations: 2 sites (Taipei, Taipei and 1 other locations)
• Trial ID: NCT05828030 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have experienced chest trauma and exhibit severe hypoxemic respiratory failure within 72 hours of their injury.

Not a fit: Patients with severe brain injuries or those who are unable to tolerate non-invasive ventilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive and more effective treatment option for patients with severe hypoxemia due to chest trauma.

How similar studies have performed: While traditional methods for managing hypoxemia in trauma patients have been established, the use of HFNC in this context is relatively novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Taipei, Taipei and 1 other locations

• 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

Conditions: Chest Trauma, Hypoxia