Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Lung Injury
• Intervention / Treatment: Device: high flow nasal cannula

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: amr hafez, M.D; Phone Number: 01225674370; Email: amr_foud@med.asu.edu.eg
• Study Contact Backup: Name: farouk Kamal, M.D; Email: faroukkamal@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: Amr Fouad, MD; Phone Number: 01225674370; Email: amr_foud@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high flow nasal cannula; will receive oxygen through high flow nasal cannula	Device: high flow nasal cannula; 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
No Intervention: oxygen mask; will receive oxygen through oxygen mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Anticipated): December 28, 2022
• Study Completion (Anticipated): December 28, 2022

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Wounds, Nonpenetrating; Respiratory Distress Syndrome; Lung Injury; Contusions
• Other Study ID Numbers: FAMSU R 116/ 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No