High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma

Blunt Injury of Thorax Clinical Trial

Official title:

High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma, a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527431
• Other study ID #: FAMSU R 115/ 2022
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: Rania Gamal
• Phone: 01006799039
• Email: rania_gamal[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blunt Injury of Thorax
• Respiratory Insufficiency
• Thoracic Injuries
• Wounds, Nonpenetrating

Intervention

Device:
• high flow nasal cannula
high flow nasal cannula
• noninvasive ventilation
noninvasive ventilation

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio	mean value of three successive PaO2/FiO2 ratio in mmHg between both groups	3 successive days
Secondary	Discomfort score	Discomfort related to oxygen delivery devices will be evaluated using a 10- point numeric scale which low number is low discomfort.	3 successive days