NCT05527431

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 4, 2024

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

August 18, 2022

Last Update Submit

June 3, 2024

Conditions

Blunt Injury of Thorax

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 ratio

    mean value of three successive PaO2/FiO2 ratio in mmHg between both groups

    3 successive days

Secondary Outcomes (1)

  • Discomfort score

    3 successive days

Study Arms (2)

high flow nasal cannula

ACTIVE COMPARATOR
Device: high flow nasal cannula

noninvasive mechanical ventilation

ACTIVE COMPARATOR
Device: noninvasive ventilation

Interventions

high flow nasal cannulaDEVICE

high flow nasal cannula

high flow nasal cannula
noninvasive ventilationDEVICE

noninvasive ventilation

noninvasive mechanical ventilation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

September 2, 2022

Study Start

August 1, 2022

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

June 4, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)