Traumatic Lung InjuryNCT05509088
Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial
A study testing high flow nasal cannula in people with Traumatic Lung Injury, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Lung Injury
- What is being tested?
- high flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jul 2022to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- chest computed tomography (CT) scan confirming the presence of lung contusion.
- Hypoxemia, indicated by a PaO2/FiO2 ratio of 100 and 200 while breathing oxygen at an FGF rate of 10 L/min via an oxygen mask, or oxygen saturation (SpO2) < 90% while on 10 L/min of oxygen, with a PaCO2 ≤ 45 mm Hg.
Who cannot join
- face trauma or surgery, airway obstruction, known to have chronic chest condition
- hemodynamic instability.
- Impaired consciousness, the need for emergency surgery, or the presence of a flail chest.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Traumatic Lung Injury
- Being tested
- high flow nasal cannula
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
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
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal cannula | Experimental | will receive oxygen through high flow nasal cannula Receives: Device: high flow nasal cannula |
| oxygen mask | No intervention | will receive oxygen through oxygen mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start28 Jul 2022
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Why it stopped: not able to het the target subject number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Lung InjuryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509088
- Sponsor's protocol ID
- FAMSU R 116/ 2022
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Early Use of High Flow Nasal Cannula in Patients With Post-traumatic Lung Contusion, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05509088
- Acronym / sponsor ID
- FAMSU R 116/ 2022
- Conditions
- Traumatic Lung Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not able to het the target subject number
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal cannula | Experimental | Device: high flow nasal cannulawill receive oxygen through high flow nasal cannula |
| oxygen mask | No intervention | –will receive oxygen through oxygen mask |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- chest computed tomography (CT) scan confirming the presence of lung contusion.
- Hypoxemia, indicated by a PaO2/FiO2 ratio of 100 and 200 while breathing oxygen at an FGF rate of 10 L/min via an oxygen mask, or oxygen saturation (SpO2) < 90% while on 10 L/min of oxygen, with a PaCO2 ≤ 45 mm Hg.
Key exclusion criteria (3 listed)
- face trauma or surgery, airway obstruction, known to have chronic chest condition
- hemodynamic instability.
- Impaired consciousness, the need for emergency surgery, or the presence of a flail chest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high flow nasal cannulaPatients 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 | Device | high flow nasal cannula |
Primary outcome
need for intubation and mechanical ventilation within 28 days of randomization.
Time frame: 3 months
the incidence of intubation in patients with lung contusion who receive oxygen through high flow nasal cannula
Results and safety
The study was stopped early (reason given: not able to het the target subject number). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula in people with Traumatic Lung Injury, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not able to het the target subject number). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
need for intubation and mechanical ventilation within 28 days of randomization. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.