Lung TraumaVentiChestNCT06735872
Effects of Non-invasive Ventilation Therapies on the Lung in Hypoxemic Chest Trauma Patients
A study testing Non invasive ventilation (NIV) and High flow oxygen therapy (HFO) in people with Lung Trauma and Lung Contusion, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Chest trauma is common in traumatology. Its management is based on ventilatory therapies, among which non-invasive ventilation (NIV) is commonly used. Some studies have shown the benefit of this therapy in hypoxemic patients, avoiding intubation, reducing length of stay and healthcare costs, and even reducing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Trauma, Lung Contusion
- What is being tested?
- Non invasive ventilation (NIV) and High flow oxygen therapy (HFO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2025to 22 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Chest trauma < 5 days
- At least 3 ribs fracture on initial CT-scan
- Need of oxygen moderated to maintain monitoring oxygen saturation Sp02 > 92% or partial pressure of arterial oxygen Pa02/ Fraction of inspired oxygen FiO2 > 200
- Intensive Care Unit admission
- Need a chest CT control during the five first days after the trauma
Who cannot join
- Patient intubated or with respiratory failure : measured or estimated Pa02/FiO2 < 200 or indication for intubation (several with respiratory rate > 35/min, abundant tracheal secretions, significant increase in work of accessory respiratory muscles on inspiration, signs of respiratory exhaustion on arterial blood gas with The potential of Hydrogen pH < 7,3 or PaCO2 > 50 mmHg, severe hypoxemia with PaO2/FiO2 ratio < 100 or desaturation < 88% for more than 5 minutes)
- Inability to maintain 10 seconds of apnoea required for scan acquisition
- Patient treated with ventilatory support by NIV or HFO in the 12 hours prior the investigation
- Uncontrolled circulatory failure with need for introduction of Noradrenaline > 0,15 ug/kg/min
- Uncontrolled neurological failure with Glasgow Coma Scale (CGS < 15
- Unstable facial trauma or with pneumocephalus or basilar skull trauma
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- Large, undrained pneumothorax with lateral separation at the level of the hilum > 2 cm and extensive throughout the axillary line
- Patients with identified cognitive impairment
- Persons deprived of liberty, persons under protective measures
- Persons not affiliated to a social security insurance
- Current pregnancy or breastfeeding
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valerie Cerro contact
France1 site, 1 recruiting
- Recruiting
Hopital Edouard Herriot
Lyon, Rhône, 69003
satnislas ABRARD, MD
About this study
Official title: Effects of Non-invasive Ventilation and High-flow Oxygen Therapy on the Lung in Hypoxemic Chest Trauma Patients, a Descriptive Experimental CT Scan Study
Chest trauma is common in traumatology. Its management is based on ventilatory therapies, among which non-invasive ventilation (NIV) is commonly used. Some studies have shown the benefit of this therapy in hypoxemic patients, avoiding intubation, reducing length of stay and healthcare costs, and even reducing mortality. However, these studies are old and underpowered. High flow oxygen therapy (HFO), which is frequently used in everyday practice, has only one study in chest trauma.
There is still a lack of data to really understand the effects of these techniques on the injured lung after trauma. Therefore, the investigators want to do a NIV or HFO session and directly assess the effects on participants' lungs by doing a CT at the end of the session.
Read more
This is a procedure carried out within five days of the initial trauma and consists of either a 10-minute session of non-invasive ventilation or a 10-minute session of high-flow oxygen therapy, depending on which arm the participant is allocated to.
Two chest CTs will be performed: the first as part of usual care before the non-invasive ventilation session or high flow oxygen therapy session, and the second immediately after the 10-minute session.
The investigator's objective is to demonstrate an improvement in lung recruitment with NIV or HFO using CT imaging.
- Conditions
- Lung Trauma, Lung Contusion
- Being tested
- Non invasive ventilation (NIV), High flow oxygen therapy (HFO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilation (NIV)Procedure or surgery
This group will receive a unique 10-minute session of non invasive ventilation with standard parameters directly on the CT table. The treatment will be delivered via a naso-buccal mask.
Prior to treatment, each participant will have a planned standard care chest CT.
During the session, a senior intensivist watching for participant's comfort and safety.
High flow oxygen therapy (HFO)Procedure or surgery
This group will receive a unique 10-minute session of high flow oxygen directly on the CT table. The treatment will be delivered via a nasal cannula.
Prior to treatment, each participant will have a planned standard care chest CT.
During the session, a senior intensivist watching for participant's comfort and safety.
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation | Experimental | This group will receive a unique 10-minute session of non invasive ventilation with standard parameters directly on the CT table. The treatment will be delivered via a naso-buccal mask. Receives: Procedure: Non invasive ventilation (NIV) |
| High flow oxygen therapy | Experimental | This group will receive a unique 10-minute session of high flow oxygen directly on the CT table. The treatment will be delivered via a nasal cannula Receives: Procedure: High flow oxygen therapy (HFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung volume
The primary outcome is evaluated by a quantitative method to compare lung volumes before and after ventilations sessions. The aim is to measure pulmonary recruitment which corresponds to the lung volume reaerated by ventilatory techniques (NIV and HFO), meaning the difference between the non-aerated lung volume between after and before the intervention. Thus, recruitment includes the partial or total re-aeration of lung areas initially not aerated before the intervention.
The senior radiologist determine the non aerated volumes on mm3 thanks to a dedicated software. We will use a semi-automatic segmentation can be carried out quickly and reproducibly.
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start22 Apr 2025
- Primary completion22 Apr 2027 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TraumaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is experimental, descriptive, prospective and monocentric. The design is with two parallel groups where each patient is his own control. That's why there is no control group. There are two groups: one receiving ten minutes of non invasive ventilation and the other one receiving ten minutes of high flow oxygen therapy. After the treatment, each participant will have an additional chest CT to determine lung volumes. To determine which group the participant is in, we use a randomisation without stratification.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735872
- Sponsor's protocol ID
- 69HCL24_1116
- Acronym
- VentiChest
- Status last verified
- Jun 2025
- First submitted
- 11 Dec 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-invasive Ventilation and High-flow Oxygen Therapy on the Lung in Hypoxemic Chest Trauma Patients, a Descriptive Experimental CT Scan Study
- ClinicalTrials.gov ID
- NCT06735872
- Acronym / sponsor ID
- VentiChest / 69HCL24_1116
- Conditions
- Lung Trauma, Lung Contusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Apr 2027 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 16 Dec 2024 (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.
Chest trauma is common in traumatology. Its management is based on ventilatory therapies, among which non-invasive ventilation (NIV) is commonly used. Some studies have shown the benefit of this therapy in hypoxemic patients, avoiding intubation, reducing length of stay and healthcare costs, and even reducing mortality. However, these studies are old and underpowered. High flow oxygen therapy (HFO), which is frequently used in everyday practice, has only one study in chest trauma.
There is still a lack of data to really understand the effects of these techniques on the injured lung after trauma. Therefore, the investigators want to do a NIV or HFO session and directly assess the effects on participants' lungs by doing a CT at the end of the session.
This is a procedure carried out within five days of the initial trauma and consists of either a 10-minute session of non-invasive ventilation or a 10-minute session of high-flow oxygen therapy, depending on which arm the participant is allocated to.
Two chest CTs will be performed: the first as part of usual care before the non-invasive ventilation session or high flow oxygen therapy session, and the second immediately after the 10-minute session.
The investigator's objective is to demonstrate an improvement in lung recruitment with NIV or HFO using CT imaging.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is experimental, descriptive, prospective and monocentric. The design is with two parallel groups where each patient is his own control. That's why there is no control group. There are two groups: one receiving ten minutes of non invasive ventilation and the other one receiving ten minutes of high flow oxygen therapy. After the treatment, each participant will have an additional chest CT to determine lung volumes. To determine which group the participant is in, we use a randomisation without stratification.
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation | Experimental | Procedure: Non invasive ventilation (NIV)This group will receive a unique 10-minute session of non invasive ventilation with standard parameters directly on the CT table. The treatment will be delivered via a naso-buccal mask. |
| High flow oxygen therapy | Experimental | Procedure: High flow oxygen therapy (HFO)This group will receive a unique 10-minute session of high flow oxygen directly on the CT table. The treatment will be delivered via a nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years old
- Chest trauma < 5 days
- At least 3 ribs fracture on initial CT-scan
- Need of oxygen moderated to maintain monitoring oxygen saturation Sp02 > 92% or partial pressure of arterial oxygen Pa02/ Fraction of inspired oxygen FiO2 > 200
- Intensive Care Unit admission
Key exclusion criteria (12 listed)
- Patient intubated or with respiratory failure : measured or estimated Pa02/FiO2 < 200 or indication for intubation (several with respiratory rate > 35/min, abundant tracheal secretions, significant increase in work of accessory respiratory muscles on inspiration, signs of respiratory exhaustion on arterial blood gas with The potential of Hydrogen pH < 7,3 or PaCO2 > 50 mmHg, severe hypoxemia with PaO2/FiO2 ratio < 100 or desaturation < 88% for more than 5 minutes)
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 |
|---|---|---|
| Non invasive ventilation (NIV)This group will receive a unique 10-minute session of non invasive ventilation with standard parameters directly on the CT table. The treatment will be delivered via a naso-buccal mask. Prior to treatment, each participant will have a planned standard care chest CT. During the session, a senior intensivist watching for participant's comfort and safety. | Procedure or surgery | Non invasive ventilation |
| High flow oxygen therapy (HFO)This group will receive a unique 10-minute session of high flow oxygen directly on the CT table. The treatment will be delivered via a nasal cannula. Prior to treatment, each participant will have a planned standard care chest CT. During the session, a senior intensivist watching for participant's comfort and safety. | Procedure or surgery | High flow oxygen therapy |
Primary outcome
lung volume
Time frame: At day 0
The primary outcome is evaluated by a quantitative method to compare lung volumes before and after ventilations sessions. The aim is to measure pulmonary recruitment which corresponds to the lung volume reaerated by ventilatory techniques (NIV and HFO), meaning the difference between the non-aerated lung volume between after and before the intervention. Thus, recruitment includes the partial or total re-aeration of lung areas initially not aerated before the intervention. The senior radiologist determine the non aerated volumes on mm3 thanks to a dedicated software. We will use a semi-automatic segmentation can be carried out quickly and reproducibly.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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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.
Valerie Cerro contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation (NIV) and High flow oxygen therapy (HFO) in people with Lung Trauma and Lung Contusion, run by Hospices Civils de Lyon at 1 site in France.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stanislas ABRARD, MD (04 72 11 69 44 ext. +33, stanislas.abrard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung volume (time frame: At day 0). 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 24 Jun 2025.