Back to resultsHigh Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma
Primary Purpose
Blunt Injury of Thorax
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high flow nasal cannula
noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Blunt Injury of Thorax
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 y,
- Willing and able to provide written informed consent prior to performing study procedures,
- currently hospitalized and requiring medical care for non-sever blunt chest trauma (abbreviated injury severity scale ≤ 2) SpO2 90% or less while breathing 10 L/min.
Exclusion Criteria:
- Contraindications of noninvasive ventilation (face trauma or surgery, airway obstruction, upper gastrointestinal tract bleeding, disturbed level of consciousness), -smoker
- intubation for any cause other than respiratory cause
Sites / Locations
- Ain Shams University hospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
high flow nasal cannula
noninvasive mechanical ventilation
Arm Description
Outcomes
Primary Outcome Measures
PaO2/FiO2 ratio
mean value of three successive PaO2/FiO2 ratio in mmHg between both groups
Secondary Outcome Measures
Discomfort score
Discomfort related to oxygen delivery devices will be evaluated using a 10- point numeric scale which low number is low discomfort.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05527431
Brief Title
High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma
Official Title
High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma, a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to compare high flow nasal cannula against noninvasive ventilation in patients with non-sever blunt chest trauma in improvement of oxygenation, need for intubation and mechanical ventilation within 28 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Injury of Thorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high flow nasal cannula
Arm Type
Active Comparator
Arm Title
noninvasive mechanical ventilation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula
Intervention Description
high flow nasal cannula
Intervention Type
Device
Intervention Name(s)
noninvasive ventilation
Intervention Description
noninvasive ventilation
Primary Outcome Measure Information:
Title
PaO2/FiO2 ratio
Description
mean value of three successive PaO2/FiO2 ratio in mmHg between both groups
Time Frame
3 successive days
Secondary Outcome Measure Information:
Title
Discomfort score
Description
Discomfort related to oxygen delivery devices will be evaluated using a 10- point numeric scale which low number is low discomfort.
Time Frame
3 successive days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 y,
Willing and able to provide written informed consent prior to performing study procedures,
currently hospitalized and requiring medical care for non-sever blunt chest trauma (abbreviated injury severity scale ≤ 2) SpO2 90% or less while breathing 10 L/min.
Exclusion Criteria:
Contraindications of noninvasive ventilation (face trauma or surgery, airway obstruction, upper gastrointestinal tract bleeding, disturbed level of consciousness), -smoker
intubation for any cause other than respiratory cause
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Gamal
Phone
01006799039
Email
rania_gamal@med.asu.edu.eg
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Fouad, MD
Phone
01225674370
Email
amr_foud@med.asu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma
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