NCT05509088

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 18, 2022

Last Update Submit

August 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

high flow nasal cannula

EXPERIMENTAL

will receive oxygen through high flow nasal cannula

Device: high flow nasal cannula

oxygen mask

NO INTERVENTION

will receive oxygen through oxygen mask

Interventions

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

high flow nasal cannula

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • face trauma or surgery, airway obstruction, known to have chronic chest condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Central Study Contacts

farouk Kamal, M.D

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 19, 2022

Study Start

July 28, 2022

Primary Completion

December 28, 2022

Study Completion

December 28, 2022

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations