HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828030
• Other study ID #: 202211029DIND
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: Hsien-Chi Liao, MD
• Phone: +886-972651611
• Email: polarisliao[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chest Trauma
• Hypoxia
• Thoracic Injuries
• Wounds and Injuries

Intervention

Procedure:
• high flow nasal cannula
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
All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) = 95%.

Locations

Country	Name	City	State
Taiwan	Department of Traumatology, National Taiwain University Hospital	Taipei
Taiwan	NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days after randomization
Secondary	P/F ratio	P/F ratio would be count at the time 0/4/12/24/48 hours after randomization	48 hrs after randomization
Secondary	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.	30 days after randomization