Acute Respiratory Distress Syndrome (ARDS)RECRUTEXNCT02081105
Validation of Digital Chest-X-ray (CXR) to Assess Lung Recruitment in ARDS
A study testing PEEP of 5 or 15 cm H2O in people with Acute Respiratory Distress Syndrome (ARDS), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- PEEP of 5 or 15 cm H2O
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Feb 2017
- 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
- intubation and mechanical ventilation in the ICU
- Ramsay score 6 under sedation and analgesia
- ICU respirator implemented with pressure-volume curve device
- age equal to or greater than 18 years
- ARDS defined from the Berlin criteria
- absence of pneumothorax on the CXR before the study
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- Absence of pleural effusion greater than 500 ml estimated from ultrasonography.
- no child-bearing woman
- written inform consent signed by the next of kin
Who cannot join
- Pneumothorax
- Pleural effusion greater than 500 ml estimated from ultrasonography
- Thoracic surgery in the last 3 months
- Contra-indication to CXR
- contra-indication to PEEP of 15 cm H2O
- contra-indication to PEEP of 15 or PEEP 15 mandated
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- pressure-volume curve not feasible
- refusal to participate
- language barrier of the next of kin
- child-bearing woman
- person under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon
Lyon, 69001
About this study
Official title: Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.
Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. The gold-standard method for assessing lung recruitability is lung CT scan. For economic and feasibility this technique cannot be used in routine. Therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. In a preliminary one-center study we found a significant negative correlation between the amount of Vrec and the reduction in lung density measured by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.
- Being tested
- PEEP of 5 or 15 cm H2O
- Keywords
- ARDS,, PEEP,, lung recruitment,, lung recruitability,, Chest-X-Ray,, lung imaging,, Pressure/Volume (PV) curve,, compliance,, respiratory mechanics
- Medical subject headings
- Respiratory Distress Syndrome, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP of 5 or 15 cm H2OOther
PEEP of 5 or 15 cm H2O set at the respirator and applied to the patient for 10 minutes. Then, measurements are made at each PEEP in the following order: arterial blood gas, CXR, pressure-volume curve.
| Study group | Role | What they receive |
|---|---|---|
| PEEP 5 | Other | level of PEEP of 5 cm H2O randomly applied to the patient Receives: Other: PEEP of 5 or 15 cm H2O |
| PEEP 15 | Other | level of PEEP of 15 cm H2O randomly applied to the patient Receives: Other: PEEP of 5 or 15 cm H2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of CXR to detect lung recruitability
1 CXR and 1 pressure-volume curve wil be performed at each PEEP for a given patient Determination of regions of interest in the posterior intercostal spaces of each lung in which density is measured to assess the total lung density at each PEEP. Measurement of Vrec between each PEEP level. One point per patient. Correlation of Vrec to change in density over all the patients and Receiver Operating Characteristic (ROC) curve of change in density to detect Vrec greater than 150 ml.
Measured: At day 1
Secondary outcomes (2)
static compliance
Static compliance will be analysed at each PEEP. End-expiratory and end-inspiratory occlusion during the tidal breath to measure the effective static compliance at each PEEP. Change in static compliance between PEEP levels.
Measured: At day 1
oxygenation
Oxygenation will be evaluated at each PEEP. Arterial blood gas measured at the end of each PEEP application for Oxygen Pressure in arterial blood (PaO2) and PaO2/ Inhaled Oxygen Fraction (FIO2) ratio.
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2017
- Study completionFeb 2017
Why it stopped: The study stopped because it was difficult to recruit the 130 expected patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hodane Yonis, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081105
- Sponsor's protocol ID
- 2013.818
- Acronym
- RECRUTEX
- Status last verified
- Jan 2022
- First submitted
- 27 Feb 2014
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.
- ClinicalTrials.gov ID
- NCT02081105
- Acronym / sponsor ID
- RECRUTEX / 2013.818
- Keywords
- ARDS,, PEEP,, lung recruitment,, lung recruitability,, Chest-X-Ray,, lung imaging,, Pressure/Volume (PV) curve,, compliance,
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped because it was difficult to recruit the 130 expected patients
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Mar 2014 (estimated)
- 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.
Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. The gold-standard method for assessing lung recruitability is lung CT scan. For economic and feasibility this technique cannot be used in routine. Therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. In a preliminary one-center study we found a significant negative correlation between the amount of Vrec and the reduction in lung density measured by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP 5 | Other | Other: PEEP of 5 or 15 cm H2Olevel of PEEP of 5 cm H2O randomly applied to the patient |
| PEEP 15 | Other | Other: PEEP of 5 or 15 cm H2Olevel of PEEP of 15 cm H2O randomly applied to the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- intubation and mechanical ventilation in the ICU
- Ramsay score 6 under sedation and analgesia
- ICU respirator implemented with pressure-volume curve device
- age equal to or greater than 18 years
- ARDS defined from the Berlin criteria
Key exclusion criteria (11 listed)
- Pneumothorax
- Pleural effusion greater than 500 ml estimated from ultrasonography
- Thoracic surgery in the last 3 months
- Contra-indication to CXR
- contra-indication to PEEP of 15 cm H2O
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 |
|---|---|---|
| PEEP of 5 or 15 cm H2OPEEP of 5 or 15 cm H2O set at the respirator and applied to the patient for 10 minutes. Then, measurements are made at each PEEP in the following order: arterial blood gas, CXR, pressure-volume curve. | Other | PEEP 15, PEEP 5 |
Primary outcome
Diagnostic performance of CXR to detect lung recruitability
Time frame: At day 1
1 CXR and 1 pressure-volume curve wil be performed at each PEEP for a given patient Determination of regions of interest in the posterior intercostal spaces of each lung in which density is measured to assess the total lung density at each PEEP. Measurement of Vrec between each PEEP level. One point per patient. Correlation of Vrec to change in density over all the patients and Receiver Operating Characteristic (ROC) curve of change in density to detect Vrec greater than 150 ml.
2 secondary outcomes
static compliance
Time frame: At day 1
oxygenation
Time frame: At day 1
Results and safety
The study was stopped early (reason given: The study stopped because it was difficult to recruit the 130 expected patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Hodane Yonis, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP of 5 or 15 cm H2O in people with Acute Respiratory Distress Syndrome (ARDS), 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 9 inclusion and 11 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 11 Jan 2022. 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: The study stopped because it was difficult to recruit the 130 expected patients). 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?
Diagnostic performance of CXR to detect lung recruitability (time frame: At day 1). 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 11 Jan 2022.