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HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

Primary Purpose

Chest Trauma, Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
high flow nasal cannula
Oxygen mask
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Trauma

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Traumatology, National Taiwain University HospitalRecruiting
  • NTUH Hsin-Chu Branch; NTUH Yun-Lin BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high flow nasal cannula group

Oxygen Mask group

Arm Description

All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at titrated from 60 L/min.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2023
Last Updated
April 24, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05828030
Brief Title
HFNC Compared With Facial Mask in Patients With Chest Trauma Patients
Official Title
Noninvasive Ventilation With High Flow Nasal Cannula Compared With Facial Mask in Patients With Chest Trauma: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma, Hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high flow nasal cannula group
Arm Type
Experimental
Arm Description
All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at titrated from 60 L/min.
Arm Title
Oxygen Mask group
Arm Type
Active Comparator
Arm Description
All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
Intervention Type
Procedure
Intervention Name(s)
high flow nasal cannula
Intervention Description
the patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
Intervention Type
Procedure
Intervention Name(s)
Oxygen mask
Intervention Description
All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
Primary Outcome Measure Information:
Title
Rate of event of intubation or pneumonia
Description
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.
Time Frame
30 days after randomization
Secondary Outcome Measure Information:
Title
P/F ratio
Description
P/F ratio would be count at the time 0/4/12/24/48 hours after randomization
Time Frame
48 hrs after randomization
Title
pneumonia rate /tracheostomy rate
Description
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.
Time Frame
30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-Chi Liao, MD
Phone
+886-972651611
Email
polarisliao@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsien-Chi Liao, MD
Organizational Affiliation
department of trauma of National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Traumatology, National Taiwain University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Chi Liao, M.D.
Phone
886-2-23123456
Ext
51611
Email
polarisliao@hotmail.com
Facility Name
NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch
City
Taipei
ZIP/Postal Code
100; 300; 640; 280
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Hsing Chen, MD
Phone
+886-972653530
Email
b96401034@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Pei-Hsing Chen, MD

12. IPD Sharing Statement

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HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

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