Blunt Injury of ThoraxNCT05527431
High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma
A study testing high flow nasal cannula and noninvasive ventilation in people with Blunt Injury of Thorax, run by Ain Shams University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blunt Injury of Thorax
- What is being tested?
- high flow nasal cannula and noninvasive ventilation
- 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
- 1 Aug 2022to 1 Apr 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma, a Randomized Clinical Trial
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
- Conditions
- Blunt Injury of Thorax
- Being tested
- high flow nasal cannula, noninvasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
high flow nasal cannula
noninvasive ventilationDevice
noninvasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal cannula | Active comparator | Not described Receives: Device: high flow nasal cannula |
| noninvasive mechanical ventilation | Active comparator | Not described Receives: Device: noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
mean value of three successive PaO2/FiO2 ratio in mmHg between both groups
Measured: 3 successive days
Secondary outcomes (1)
Discomfort score
Discomfort related to oxygen delivery devices will be evaluated using a 10- point numeric scale which low number is low discomfort.
Measured: 3 successive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Injury of ThoraxStudies 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
- Treatment
- 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
- NCT05527431
- Sponsor's protocol ID
- FAMSU R 115/ 2022
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2022
- Last updated
- 4 Jun 2024
- Results posted
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula vs Noninvasive Ventilation in Patients With Hypoxic Respiratory Failure Following Blunt Chest Trauma, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05527431
- Acronym / sponsor ID
- FAMSU R 115/ 2022
- Conditions
- Blunt Injury of Thorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 Sep 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal cannula | Active comparator | Device: high flow nasal cannula |
| noninvasive mechanical ventilation | Active comparator | Device: noninvasive ventilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 cannulahigh flow nasal cannula | Device | high flow nasal cannula |
| noninvasive ventilationnoninvasive ventilation | Device | noninvasive mechanical ventilation |
Primary outcome
PaO2/FiO2 ratio
Time frame: 3 successive days
mean value of three successive PaO2/FiO2 ratio in mmHg between both groups
1 secondary outcome
Discomfort score
Time frame: 3 successive days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- 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 and noninvasive ventilation in people with Blunt Injury of Thorax, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jun 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PaO2/FiO2 ratio (time frame: 3 successive days). 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 4 Jun 2024.