HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

Last updated: July 15, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Trauma

Treatment

Oxygen mask

high flow nasal cannula

Clinical Study ID

NCT05828030
202211029DIND
  • Ages 20-99
  • All Genders

Study 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). Therefore, Our aim was to determine whether HFNC reduces intubation in severe trauma-related hypoxemia.

Eligibility Criteria

Inclusion

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 respiratorydistress

  • PaCO2 of 45 mmHg or higher (if the patient requires emergency surgery withendotracheal intubation and mechanical ventilation, the time of inclusion will bethe start of the post-extubation period. (Note: For patients who receive emergencytrauma surgery with endotracheal intubation and mechanical ventilation, the time ofinclusion assessment will be 72 hours after extubation.)

Exclusion

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 acutegastrointestinal bleeding, upper airway obstruction, or hemodynamic instability.

  3. Facial trauma involving skull base fractures, facial bone fractures, or orbitalfloor 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 thatprevents the use of appropriate nasal cannula.

  8. Patients after upper airway surgery.

  9. Patients who are unable to clearly express their willingness to sign informedconsent.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Oxygen mask
Phase:
Study Start date:
April 26, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Department of Traumatology, National Taiwain University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch

    Taipei, 100; 300; 640; 280
    Taiwan

    Active - Recruiting

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