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NCT Number: NCT05828030

HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

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.

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Key information

Conditions

Chest Trauma Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Injuries Wounds and Injuries

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Traumatology, National Taiwain University Hospital, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.
  • 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.

Treatment and study plan

high flow nasal cannula

Procedure

the patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

Oxygen mask

Procedure

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

Primary outcomes

  1. 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.

Secondary outcomes

  1. P/F ratio

    Time frame: 48 hrs after randomization

    P/F ratio would be count at the time 0/4/12/24/48 hours after randomization

  2. pneumonia rate /tracheostomy rate

    Time frame: 30 days after randomization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hsien-Chi Liao, MD

CONTACT

[email protected]

+886-972651611

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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