Acute Respiratory Distress SyndromSRIMSANCT06609629
Selective Lung Recruitment in Moderate to Severe ARDS : a Pilot Study
A study testing Selective lung recruitment in people with Acute Respiratory Distress Syndrom, run by University Hospital, Caen.
Trial summary
Acute respiratory distress syndrome (ARDS) is an acute condition affecting the lung after clinical aggression ( infectious process, pancreatitis, acute inflammatory event). This condition lead to major breathlessness due to the incapacity to properly oxygenize the boby because of lung lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrom
- What is being tested?
- Selective lung recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to Sep 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
- acute ARDS according Berlin definition and a PaO2/FiO2 ratio inferior to 200
- patient under sedation and muscular blockade
- postero-basal consolidation on CT or pulmonary ultrasound
- affiliated to the French social insurance system
Who cannot join
- hemodynamic instability
- pregnancy
- patient under guardianship
Trial locations and contacts
No sites are listed yet.
About this study
Acute respiratory distress syndrome (ARDS) is an acute condition affecting the lung after clinical aggression ( infectious process, pancreatitis, acute inflammatory event). This condition lead to major breathlessness due to the incapacity to properly oxygenize the boby because of lung lesions. Invasive mechanical ventilation is frequently required to grant sufficient oxygenation to the body. Unfortunately, while it allows oxygenation, mechanical ventilation can cause arms to the lung because of the mechanical power it delivers to the lung and create ventilation induced lung injuries (VILI). To reduce this risk, ventilator settings have been protocolized aiming to reduce the lung volume administered to the lung. It is effective to control the VILI but oxygenation may be insufficient under those protective parameters. To correct this lack of oxygenation practicians use recruiting maneuvers when a transient increase of lung volume administered to the lung to open collapse parts of the lung. Those maneuvers can cause barotrauma and provoke pneumothorax or decrease the heart flow. This study aim to assess the feasibility of selective recruitment maneuvers to increase oxygenation while reducing the risk of recruitment maneuvers.
Briefly, a dedicated bronchial blocker is introduce in a lower part of the lung, a balloon attached to the catheter is expended isolating a part of the lung and a recruiting pressure is administered through the lumen of the catheter to selectively expend the isolated part of the lung.
After the selected recruitment maneuver, the investigators will assess the expansion of the lung with a CT-scanner.
- Conditions
- Acute Respiratory Distress Syndrom
- Being tested
- Selective lung recruitment
- Keywords
- ARDS, Recruitment maneuvers, selective recruitment maneuvers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective lung recruitmentProcedure or surgery
A bronchial blocker with a lumen is inserted in one inferior pulmonary lobe using a fibroscope. The baloon of the blocker is expended to isolate the lobe. A second ventilator is used to apply a pressure of 45cmH2o through the lumen of the blocker. The recruiting pressure is maintained 30 to 60 second. After the procedure, the blocker is removed and the procedure is repeated in the controlateral inferior lobe.
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | This is a feasibility study. One arm of 10 patients is needed Receives: Procedure: Selective lung recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison in lung aeration before and after the recruiting manouever
Differance in lung aeration wil be assess with comparison between lung aeration on a chest CT-scan before the recruiting maneuver and lung aeration on a chest CT-scan after the recruitment maneuver. The principal outcome will be the ratio of normaly aerated lung volume (%)/hyperinflated lung volume (%). The higher this ratio will be the better is the recruitment (high volume recruited and low volume hyperinflated). The level of aeration of the lung will be determined using the density level on CT-scan where lung area will be classified among 4 category according a level of hounsfield unit (non aerated :density betwen +100 et -100 Hounsfield unit ; poorly aerated: density betwen -101 et -500 Hounsfield unit; normaly aerated: density betwen -501 et -900 Hounsfield unit; hyperinflated (density betwen -901 et -1000 Hounsfield unit). Each area will be quantified using AquariusTM software.
Measured: the sthe second CT will be perform between hour 4 and hour 8 after the maneuver (Hour 0).
Secondary outcomes (2)
difference between lung impedance before and after selective recruitment maneuvers
measure of lung impedance using an electrical impedance tomodensitometry device (pulmovista Dräger)
Measured: measured immedialtly before the recruitment maneuver (hour 0), between hour 4 to hour 8 after the recruitiment maneuver , at hour 24 after the selective recruitment maneuver
PaO2/FiO2 ratio
Measured: measured immedialtly before the recruitment maneuver (hour 0), between hour 4 to hour 8 after the recruitiment maneuver , at hour 24 after the selective recruitment maneuver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609629
- Sponsor's protocol ID
- 2024-A00005-42
- Acronym
- SRIMSA
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Lung Recruitment in Moderate to Severe ARDS : a Pilot Study
- ClinicalTrials.gov ID
- NCT06609629
- Acronym / sponsor ID
- SRIMSA / 2024-A00005-42
- Conditions
- Acute Respiratory Distress Syndrom
- Keywords
- ARDS, Recruitment maneuvers, selective recruitment maneuvers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Sep 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.
Acute respiratory distress syndrome (ARDS) is an acute condition affecting the lung after clinical aggression ( infectious process, pancreatitis, acute inflammatory event). This condition lead to major breathlessness due to the incapacity to properly oxygenize the boby because of lung lesions. Invasive mechanical ventilation is frequently required to grant sufficient oxygenation to the body. Unfortunately, while it allows oxygenation, mechanical ventilation can cause arms to the lung because of the mechanical power it delivers to the lung and create ventilation induced lung injuries (VILI). To reduce this risk, ventilator settings have been protocolized aiming to reduce the lung volume administered to the lung. It is effective to control the VILI but oxygenation may be insufficient under those protective parameters. To correct this lack of oxygenation practicians use recruiting maneuvers when a transient increase of lung volume administered to the lung to open collapse parts of the lung. Those maneuvers can cause barotrauma and provoke pneumothorax or decrease the heart flow. This study aim to assess the feasibility of selective recruitment maneuvers to increase oxygenation while reducing the risk of recruitment maneuvers.
Briefly, a dedicated bronchial blocker is introduce in a lower part of the lung, a balloon attached to the catheter is expended isolating a part of the lung and a recruiting pressure is administered through the lumen of the catheter to selectively expend the isolated part of the lung.
After the selected recruitment maneuver, the investigators will assess the expansion of the lung with a CT-scanner.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Procedure: Selective lung recruitmentThis is a feasibility study. One arm of 10 patients is needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute ARDS according Berlin definition and a PaO2/FiO2 ratio inferior to 200
- patient under sedation and muscular blockade
- postero-basal consolidation on CT or pulmonary ultrasound
- affiliated to the French social insurance system
Key exclusion criteria (3 listed)
- hemodynamic instability
- pregnancy
- patient under guardianship
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 |
|---|---|---|
| Selective lung recruitmentA bronchial blocker with a lumen is inserted in one inferior pulmonary lobe using a fibroscope. The baloon of the blocker is expended to isolate the lobe. A second ventilator is used to apply a pressure of 45cmH2o through the lumen of the blocker. The recruiting pressure is maintained 30 to 60 second. After the procedure, the blocker is removed and the procedure is repeated in the controlateral inferior lobe. | Procedure or surgery | interventional arm |
Primary outcome
comparison in lung aeration before and after the recruiting manouever
Time frame: the sthe second CT will be perform between hour 4 and hour 8 after the maneuver (Hour 0).
Differance in lung aeration wil be assess with comparison between lung aeration on a chest CT-scan before the recruiting maneuver and lung aeration on a chest CT-scan after the recruitment maneuver. The principal outcome will be the ratio of normaly aerated lung volume (%)/hyperinflated lung volume (%). The higher this ratio will be the better is the recruitment (high volume recruited and low volume hyperinflated). The level of aeration of the lung will be determined using the density level on CT-scan where lung area will be classified among 4 category according a level of hounsfield unit (non aerated :density betwen +100 et -100 Hounsfield unit ; poorly aerated: density betwen -101 et -500 Hounsfield unit; normaly aerated: density betwen -501 et -900 Hounsfield unit; hyperinflated (density betwen -901 et -1000 Hounsfield unit). Each area will be quantified using AquariusTM software.
2 secondary outcomes
difference between lung impedance before and after selective recruitment maneuvers
Time frame: measured immedialtly before the recruitment maneuver (hour 0), between hour 4 to hour 8 after the recruitiment maneuver , at hour 24 after the selective recruitment maneuver
PaO2/FiO2 ratio
Time frame: measured immedialtly before the recruitment maneuver (hour 0), between hour 4 to hour 8 after the recruitiment maneuver , at hour 24 after the selective recruitment maneuver
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Distress Syndrom
RecruitingObservational study
Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.
Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
EIT Assessment of Overdistension in ARDS Patients in Prone Position
Acute Respiratory Distress Syndrome
Recruiting
LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly
Dyspnea, Respiratory Distress Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A study testing Selective lung recruitment in people with Acute Respiratory Distress Syndrom, run by University Hospital, Caen.
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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Cuchet, MD (33231064716, cuchet-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison in lung aeration before and after the recruiting manouever (time frame: the sthe second CT will be perform between hour 4 and hour 8 after the maneuver (Hour 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 Sep 2024.