Back to resultsImpact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial
Primary Purpose
Traumatic Lung Injury
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high flow nasal cannula
Sponsored by
About this trial
This is an interventional prevention trial for Traumatic Lung Injury
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide written informed consent prior to performing study procedures, currently hospitalized and requiring medical care for blunt chest trauma, within 24h of trauma
Exclusion Criteria:
- face trauma or surgery, airway obstruction, known to have chronic chest condition
Sites / Locations
- Ain Shams University hospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
high flow nasal cannula
oxygen mask
Arm Description
will receive oxygen through high flow nasal cannula
will receive oxygen through oxygen mask
Outcomes
Primary Outcome Measures
need for intubation and mechanical ventilation within 28 days of randomization.
the incidence of intubation in patients with lung contusion who receive oxygen through high flow nasal cannula
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05509088
Brief Title
Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial
Official Title
Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
December 28, 2022 (Anticipated)
Study Completion Date
December 28, 2022 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
We hypothesize that early and continuous administration of oxygen via high flow nasal cannula in patients with lung contusion and non-severe acute lung injury might reduce the incidence of intubation and hold the deterioration of pulmonary functions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Lung Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high flow nasal cannula
Arm Type
Experimental
Arm Description
will receive oxygen through high flow nasal cannula
Arm Title
oxygen mask
Arm Type
No Intervention
Arm Description
will receive oxygen through oxygen mask
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula
Intervention Description
Patients in the intervention group receive oxygen through HFNC with a flow rate of set initially at 40 L / min, FiO2 adjusted to maintain SpO2 ≥ 92%, and will be humidified, heated to 34-37 °C, disconnection will be allowed only when ambulation is required, patients will be instructed to practice mouth closing throughout the HFNC therapy as much as possible
Primary Outcome Measure Information:
Title
need for intubation and mechanical ventilation within 28 days of randomization.
Description
the incidence of intubation in patients with lung contusion who receive oxygen through high flow nasal cannula
Time Frame
3 months
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:
Willing and able to provide written informed consent prior to performing study procedures, currently hospitalized and requiring medical care for blunt chest trauma, within 24h of trauma
Exclusion Criteria:
face trauma or surgery, airway obstruction, known to have chronic chest condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amr hafez, M.D
Phone
01225674370
Email
amr_foud@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
farouk Kamal, M.D
Email
faroukkamal@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
Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial
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