Thoracic InjuriesOpti-PEPNCT06072339
Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation (Opti-PEP).
A study testing Lung Ultrasound for PEEP setting, Non invasive ventilation session and Arterial blood gas in people with Thoracic Injuries and Non-invasive Ventilation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies.Patients may be included if they present with acute respiratory failure related to blunt chest trauma.The intervention group will benefit from the use by the physiotherapist of pulmonary ultrasound for the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Injuries, Non-invasive Ventilation
- What is being tested?
- Lung Ultrasound for PEEP setting, Non invasive ventilation session and Arterial blood gas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2023to 29 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or more
- Admitted to intensive care or continuing care for 72 hours or less for blunt chest trauma, defined by the presence of at least one of the following elements on the initial CT scan: fracture(s) of rib(s) / fracture(s) of the sternum / pulmonary contusion / hemothorax
- Acute hypoxemic respiratory failure defined by the administration of oxygen at least 3 L/min with nasal cannula or FiO2≥30% if high flow oxygen therapy.
- Patient with a functional arterial catheter for blood tests
Who cannot join
- Acute respiratory distress, defined by the presence of at least one of the following clinical signs: respiratory rate ˃ 35 / use of accessory inspirators / paradoxal abdominal or thoracic motion
- Imminent need for invasive mechanical ventilation
- Usual contraindication to non-invasive ventilation (undrained pneumothorax, trauma to the face, vigilance disorders, digestive bleeding, hemodynamic instability, intolerance)
- Hypercapnia (PaCO2˃45mmHg)
- Patient unable to cooperate, communicate
- Therapeutic limitation
Show all 14Show fewer
- Expected length of stay ≤ 48h
- Severe head trauma
- Pregnant or breastfeeding women
- Participation in other clinical research related to respiratory failure/respiratory therapy
- Vulnerable people
- Protected adults, under guardianship or curatorship, or unable to give consent
- Non-affiliated person or beneficiary of a social security scheme
- Absence of free, informed and written consent, signed by the participant and the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation : Randomized Controlled Study (Opti-PEP).
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies.Patients may be included if they present with acute respiratory failure related to blunt chest trauma.The intervention group will benefit from the use by the physiotherapist of pulmonary ultrasound for the adjustment of Positive End Expiratory Pressure (PEEP) during the 1st session. The conventional group will benefit from the non-invasive ventilation according to the current care.
Read the detailed description
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies. Patients may be included if they are admitted to intensive care unit or continuing care unit and present with acute respiratory failure related to blunt chest trauma. We will not include patients with another indication for non-invasive ventilation, immediately needing invasive ventilation, a contraindication to non invasive ventilation or an estimated length of stay less than or equal to 48 hours.
Both groups will be treated with non-ivasive ventilation according to the medical prescription. The intervention group will benefit from the use by the physiotherapist of pulmonary ultrasound for the adjustment of PEEP during the 1st session. The conventional group will benefit from the non-invasive ventilation according to the usual care. The other non-invasive ventilation settings will be chosen with the same method in both groups.
The main endpoint will be the PaO2/FiO2 ratio (Arterial oxygen pressure / inspired fraction of oxygen) after 30 min of non-invasive ventilation treatment. This ratio is the best reflection of the patient oxygenation and currently used for respiratory therapies studies.
- Conditions
- Thoracic Injuries, Non-invasive Ventilation
- Being tested
- Lung Ultrasound for PEEP setting, Non invasive ventilation session, Arterial blood gas, Interview on pain and comfort
- Keywords
- thoracic injuries, non-invasive ventilation, Positive End Expiratory Pressure, Ultrasonography
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound for PEEP settingOther
NIV is started and adjusted by the physiotherapist. For the adjustment of PEEP, the ultrasound probe is placed on the thorax, facing the intercostal space having obtained the highest score during the initial LUS (synonym of the worst pulmonary aeration) and the images observed in real time. PEEP is increased until the physiotherapist cannot see any additional benefit on pulmonary aeration or appearance of a patient discomfort or an increasing of air leaks.
Non invasive ventilation sessionProcedure or surgery
The session will be done via a mouthpiece preferably, or a face mask if it is impossible for the patient to close their mouth properly or to hold the mouthpiece.
The duration of the NIV session will be defined by the prescribing doctor (usually between 30 and 60 minutes), without being able to be less than 30 minutes. The session will be stopped in the event of the appearance of one of the contraindications to NIV mentioned above.
Arterial blood gasBiological
Arterial blood gas will be done at inclusion, at Visit 1 (at the 30th minute from the start of the 1st Non-invasive ventilation session) and at Visit 2 (at the 60th minute from the start of the 1st Non-invasive ventilation session) in both groups of patients in order to calculate the Pa02/Fi02 ratio.
Interview on pain and comfortOther
The investigator physiotherapist interviews the participant to measure pain and comfort scores using a visual analogue scale (score from 0 to 10).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session. Receives: Other: Lung Ultrasound for PEEP setting; Procedure: Non invasive ventilation session; Biological: Arterial blood gas; Other: Interview on pain and comfort |
| Control | Active comparator | The conventional group will benefit from the NIV under the current terms. Receives: Procedure: Non invasive ventilation session; Biological: Arterial blood gas; Other: Interview on pain and comfort |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups
PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups.
This PaO2/FiO2 ratio is now the benchmark for qualifying the severity of the respiratory impairment or measuring the response to a mechanical ventilation strategy aimed at improving oxygenation.
Measured: at the 30th minute from the start of the 1st Non-invasive ventilation session
Secondary outcomes (9)
Comparaison of the Lung Ultrasound Score (LUS) in both groups
Comparaison of the Lung Ultrasound Score (LUS) in both groups. The LUS ranges from 0 to 36. Rib cage is divided into 12 areas (6 for each side) and each area is assessed according to the following scale:
0: Normal aeration corresponding to presence of lung sliding with A lines or fewer than two isolated B lines
- Moderate loss of lung aeration corresponding to multiple well-defined B lines or spaced ultrasound lung called 'cornet-tail artifact"
- Severe loss of lung aeration corresponding to multiple coalescent B lines or multiple abutting ultrasound lung cornet-tails issued from the pleural line
- Lung consolidation corresponding to presence of a tissue pattern containing hyperechoic punctiform images representative of air bronchograms. Presence or absence of regional pulmanory blood flow and/or dynamic bronchograms.
Measured: at the 30th minute from the start of the 1st Non-invasive ventilation session
Comparaison of the PEEP value set at the start of the non-invasive ventilation session
Comparaison of the PEEP value set (in cmH2O) in both groups
Measured: At the start of the non-invasive ventilation session
Comparaison of the confort value in both groups
Comparaison of the confort value in both groups using the Confort Visual Analog scale (from 0 to 10)
Measured: at the 30th minute from the start of the 1st Non-invasive ventilation session
Comparaison of the pain value in both groups
Comparaison of the pain value in both groups using the Pain Visual Analog scale (from 0 to 10)
Measured: at the 30th minute from the start of the 1st Non-invasive ventilation session
Comparaison of the PaO2/FiO2 ratio in both groups
Comparaison of the PaO2/FiO2 ratio in both groups
Measured: 1 hour after the end of the 1st non-invasive ventilation session
Comparaison of the incidence rate of respiratory aggravation in the 2 groups
Comparaison of the incidence rate of respiratory aggravation in the 2 groups
Measured: Until discharge from intensive care/continuous care or until maximum D7.
Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of non-invasive ventilation is possible
Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of NIV is possible
Measured: at the 30th minute from the start of the 1st Non-invasive ventilation session
PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation
PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation
Measured: at the 30th minute from the start of the 1st Non-invasive ventilation session
PaO2/FiO2 ratio in both groups in patients with pleural effusion
PaO2/FiO2 ratio in the 2 groups in patients with pleural effusion
Measured: at the 30th minute from the start of the 1st Non-invasive ventilation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start19 Dec 2023
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Why it stopped: changes in patient care that move them further away from the inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-labeled, controlled, randomized study
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072339
- Sponsor's protocol ID
- RECHMPL22_0556
- Acronym
- Opti-PEP
- Status last verified
- May 2026
- First submitted
- 2 Oct 2023
- Last updated
- 1 Jun 2026
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Positive End Expiratory Pressure by Use of Pulmonary Ultrasound for Patients With Blunt Chest Trauma Treated by Non-Invasive Ventilation : Randomized Controlled Study (Opti-PEP).
- ClinicalTrials.gov ID
- NCT06072339
- Acronym / sponsor ID
- Opti-PEP / RECHMPL22_0556
- Conditions
- Thoracic Injuries, Non-invasive Ventilation
- Keywords
- thoracic injuries, non-invasive ventilation, Positive End Expiratory Pressure, Ultrasonography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: changes in patient care that move them further away from the inclusion criteria
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 10 Oct 2023 (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.
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies.Patients may be included if they present with acute respiratory failure related to blunt chest trauma.The intervention group will benefit from the use by the physiotherapist of pulmonary ultrasound for the adjustment of Positive End Expiratory Pressure (PEEP) during the 1st session. The conventional group will benefit from the non-invasive ventilation according to the current care.
Detailed description
This is an open-label, randomized controlled study comparing two non-invasive ventilation initiation strategies. Patients may be included if they are admitted to intensive care unit or continuing care unit and present with acute respiratory failure related to blunt chest trauma. We will not include patients with another indication for non-invasive ventilation, immediately needing invasive ventilation, a contraindication to non invasive ventilation or an estimated length of stay less than or equal to 48 hours.
Both groups will be treated with non-ivasive ventilation according to the medical prescription. The intervention group will benefit from the use by the physiotherapist of pulmonary ultrasound for the adjustment of PEEP during the 1st session. The conventional group will benefit from the non-invasive ventilation according to the usual care. The other non-invasive ventilation settings will be chosen with the same method in both groups.
The main endpoint will be the PaO2/FiO2 ratio (Arterial oxygen pressure / inspired fraction of oxygen) after 30 min of non-invasive ventilation treatment. This ratio is the best reflection of the patient oxygenation and currently used for respiratory therapies studies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-labeled, controlled, randomized study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Lung Ultrasound for PEEP setting, Procedure: Non invasive ventilation session, Biological: Arterial blood gas, Other: Interview on pain and comfortThe intervention group will benefit from the physiotherapist's use of lung ultrasound for the PEEP adjustment during the first NIV session. |
| Control | Active comparator | Procedure: Non invasive ventilation session, Biological: Arterial blood gas, Other: Interview on pain and comfortThe conventional group will benefit from the NIV under the current terms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 or more
- Admitted to intensive care or continuing care for 72 hours or less for blunt chest trauma, defined by the presence of at least one of the following elements on the initial CT scan: fracture(s) of rib(s) / fracture(s) of the sternum / pulmonary contusion / hemothorax
- Acute hypoxemic respiratory failure defined by the administration of oxygen at least 3 L/min with nasal cannula or FiO2≥30% if high flow oxygen therapy.
- Patient with a functional arterial catheter for blood tests
Key exclusion criteria (14 listed)
- Acute respiratory distress, defined by the presence of at least one of the following clinical signs: respiratory rate ˃ 35 / use of accessory inspirators / paradoxal abdominal or thoracic motion
- Imminent need for invasive mechanical ventilation
- Usual contraindication to non-invasive ventilation (undrained pneumothorax, trauma to the face, vigilance disorders, digestive bleeding, hemodynamic instability, intolerance)
- Hypercapnia (PaCO2˃45mmHg)
- Patient unable to cooperate, communicate
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 |
|---|---|---|
| Lung Ultrasound for PEEP settingNIV is started and adjusted by the physiotherapist. For the adjustment of PEEP, the ultrasound probe is placed on the thorax, facing the intercostal space having obtained the highest score during the initial LUS (synonym of the worst pulmonary aeration) and the images observed in real time. PEEP is increased until the physiotherapist cannot see any additional benefit on pulmonary aeration or appearance of a patient discomfort or an increasing of air leaks. | Other | Experimental |
| Non invasive ventilation sessionThe session will be done via a mouthpiece preferably, or a face mask if it is impossible for the patient to close their mouth properly or to hold the mouthpiece. The duration of the NIV session will be defined by the prescribing doctor (usually between 30 and 60 minutes), without being able to be less than 30 minutes. The session will be stopped in the event of the appearance of one of the contraindications to NIV mentioned above. | Procedure or surgery | Control, Experimental |
| Arterial blood gasArterial blood gas will be done at inclusion, at Visit 1 (at the 30th minute from the start of the 1st Non-invasive ventilation session) and at Visit 2 (at the 60th minute from the start of the 1st Non-invasive ventilation session) in both groups of patients in order to calculate the Pa02/Fi02 ratio. | Biological | Control, Experimental |
| Interview on pain and comfortThe investigator physiotherapist interviews the participant to measure pain and comfort scores using a visual analogue scale (score from 0 to 10). | Other | Control, Experimental |
Primary outcome
PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups
Time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups. This PaO2/FiO2 ratio is now the benchmark for qualifying the severity of the respiratory impairment or measuring the response to a mechanical ventilation strategy aimed at improving oxygenation.
9 secondary outcomes
Comparaison of the Lung Ultrasound Score (LUS) in both groups
Time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
Comparaison of the PEEP value set at the start of the non-invasive ventilation session
Time frame: At the start of the non-invasive ventilation session
Comparaison of the confort value in both groups
Time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
Comparaison of the pain value in both groups
Time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
Comparaison of the PaO2/FiO2 ratio in both groups
Time frame: 1 hour after the end of the 1st non-invasive ventilation session
Comparaison of the incidence rate of respiratory aggravation in the 2 groups
Time frame: Until discharge from intensive care/continuous care or until maximum D7.
Rate of patients included in the experimental group in whom the use of ultrasound during the initiation of non-invasive ventilation is possible
Time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
PaO2/FiO2 ratio in both groups in patients with pulmonary consolidation
Time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
PaO2/FiO2 ratio in both groups in patients with pleural effusion
Time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session
Results and safety
The study was stopped early (reason given: changes in patient care that move them further away from the inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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 Lung Ultrasound for PEEP setting, Non invasive ventilation session and Arterial blood gas in people with Thoracic Injuries and Non-invasive Ventilation, run by University Hospital, Montpellier 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 4 inclusion and 14 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 1 Jun 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 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?
The study was stopped early (reason given: changes in patient care that move them further away from the inclusion criteria). 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?
PaO2/FiO2 ratio (Arterial oxygen pressure / inspired oxygen fraction) in both groups (time frame: at the 30th minute from the start of the 1st Non-invasive ventilation session). 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 1 Jun 2026.