Respiratory Distress Syndrome, AdultOPPREDNCT04028336
The Strategy of "Pulmonary Opening by Titration of Positive End-expiratory Pressure" Means of a Pulmonary Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: for Which Patients?
A study testing TITRATION in people with Respiratory Distress Syndrome, Adult, run by Centre Hospitalier de Lens at 4 sites in France.
Trial summary
Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- TITRATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Dec 2019to 7 Jan 2021
- 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
- Will be included in the study, patients:
- Major patient (age ≥18 years)
- Controlled assisted ventilation, sedation and curarization adapted to the respirator.
- Within the first 72 hours of an ARDS (PaO2 / FiO2 ≤ 200 mmHg, FiO2 ≥ 60% and PEEP of ≥5 cmH20) (as recommended by the Berlin criteria)
- Decision of intensivist in charge of the patient to put an oesophageal probe
- After hemodynamic optimization (evaluation of the preload dependence and need for catecholamines)
- Decision of the intensivist in charge of the patient to perform a pulmonary opening test by titration of PEEP by means of a pulmonary recruitment test.
Who cannot join
- Patients under the age of 18
- Pregnant women, women who are parturient or breastfeeding
- Patients with pulmonary broncho-emphysematous pathology or at risk of presenting it.
- Patients with a history of barotrauma or at risk of presenting it.
- Patients with a history of intracranial hypertension
- Patients with suspected or proven right ventricular dysfunction or uncontrolled hemodynamic instability after hemodynamic management.
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- Patients with a contraindication to the placement of an oesophageal tube (esophageal surgery, severe esophageal pathology)
- Patients under guardianship or curatorship or deprived of liberty.
- Patients who are legally protected
- Patient not covered by French national health insurance
Trial locations and contacts
4 sites in 1 country.
France4 sites
Chu Amiens
Amiens, 80054
CH Arras
Arras, 62000
Ch Germon Et Gauthier
Béthune, 62408
Hospital Dr Schaffner
Lens, 62307
About this study
Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Its beneficial effects in the lung affected by Acute Respiratory Distress Syndrome (ARDS) remain unclear. The hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ARDS. It is important to be able to define responder patients from non-responders to this recruiting maneuver.
Read the detailed description
It will be a prospective interventional study in resuscitation patients with severe or moderate ARDS. This study will be multicentric between the University Hospital of Amiens and intensive care of Lens, intensive care of Bethune and intensive care of Arras. All patients in intensive care and severe, moderate ARDS will be included in this study. All patients will benefit from Lung ultrasound (LUS) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (Peso) at rest. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- TITRATION
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TITRATIONOther
PEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement.
| Study group | Role | What they receive |
|---|---|---|
| TITRATION | Experimental | All patients hospitalized in intensive care and meeting inclusion criteria and without criteria for non-inclusion will be included in this study. All patients will benefit from Lung ultrasound (LUS) and esophageal pressure measurement (Peso) according to the habits of the service. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement. Receives: Other: TITRATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation and pulmonary compliance
The primary outcome is oxygenation (PaO2 / FiO2) and pulmonary compliance ((Pplat-Pep) / VT) at 1h of the PEP-OP test.
Measured: at 1 hours of the PEP-OP test.
Secondary outcomes (6)
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Measured: at 6 hours, 12 hours, 24 hours of the PEP-OP test
Mechanical ventilation time
Mechanical ventilation time
Measured: Discharge from intensive care unit
Hospitalization in intensive care time
Hospitalization in intensive care time
Measured: Discharge from intensive care unit
The need for recourse to alternative therapies of oxygenation
The need for recourse to alternative therapies of oxygenation
Measured: Discharge from intensive care unit
Incidence of barotrauma
Incidence of barotrauma
Measured: After PEP-OP
Pulmonary compliance at 6 hours, 12 hours and 24 hours
Pulmonary compliance at 6 hours, 12 hours and 24 hours
Measured: at 6 hours, 12 hours and 24 hours of the PEP-OP test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start20 Dec 2019
- Primary completion7 Jan 2021
- Study completion7 Jan 2021
Why it stopped: Technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients in intensive care and severe, moderate ARDS will be included in this study. All patients will benefit from Lung ultrasound (LUS) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (Peso) at rest. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Lens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien MARC, DR, Principal investigator, Hospital of Lens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028336
- Sponsor's protocol ID
- PI2019-01/OPPRED/DRMARC
- Acronym
- OPPRED
- Status last verified
- Mar 2021
- First submitted
- 9 Jul 2019
- Last updated
- 4 Mar 2021
- 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 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Strategy of "Pulmonary Opening by Titration of Positive End-expiratory Pressure" Means of a Pulmonary Recruitment Maneuver in Patients With Acute Respiratory Distress Syndrome: for Which Patients?
- ClinicalTrials.gov ID
- NCT04028336
- Acronym / sponsor ID
- OPPRED / PI2019-01/OPPRED/DRMARC
- Conditions
- Respiratory Distress Syndrome, Adult
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier de LensUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 7 Jan 2021 (actual)
- First posted
- 22 Jul 2019 (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.
Pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (PEP) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. Its beneficial effects in the lung affected by Acute Respiratory Distress Syndrome (ARDS) remain unclear. The hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ARDS. It is important to be able to define responder patients from non-responders to this recruiting maneuver.
Detailed description
It will be a prospective interventional study in resuscitation patients with severe or moderate ARDS. This study will be multicentric between the University Hospital of Amiens and intensive care of Lens, intensive care of Bethune and intensive care of Arras. All patients in intensive care and severe, moderate ARDS will be included in this study. All patients will benefit from Lung ultrasound (LUS) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (Peso) at rest. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients in intensive care and severe, moderate ARDS will be included in this study. All patients will benefit from Lung ultrasound (LUS) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (Peso) at rest. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement.
| Arm | Type | Receives |
|---|---|---|
| TITRATION | Experimental | Other: TITRATIONAll patients hospitalized in intensive care and meeting inclusion criteria and without criteria for non-inclusion will be included in this study. All patients will benefit from Lung ultrasound (LUS) and esophageal pressure measurement (Peso) according to the habits of the service. A "PEP titration pulmonary opening" (PEP-OP) test using a recruitment maneuver was then performed in all patients followed by a new LUS and Peso measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Major patient (age ≥18 years)
- Controlled assisted ventilation, sedation and curarization adapted to the respirator.
- Within the first 72 hours of an ARDS (PaO2 / FiO2 ≤ 200 mmHg, FiO2 ≥ 60% and PEEP of ≥5 cmH20) (as recommended by the Berlin criteria)
- Decision of intensivist in charge of the patient to put an oesophageal probe
- After hemodynamic optimization (evaluation of the preload dependence and need for catecholamines)
Key exclusion criteria (10 listed)
- Patients under the age of 18
- Pregnant women, women who are parturient or breastfeeding
- Patients with pulmonary broncho-emphysematous pathology or at risk of presenting it.
- Patients with a history of barotrauma or at risk of presenting it.
- Patients with a history of intracranial hypertension
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 |
|---|---|---|
| TITRATIONPEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement. | Other | TITRATION |
Primary outcome
oxygenation and pulmonary compliance
Time frame: at 1 hours of the PEP-OP test.
The primary outcome is oxygenation (PaO2 / FiO2) and pulmonary compliance ((Pplat-Pep) / VT) at 1h of the PEP-OP test.
6 secondary outcomes
Oxygenation (PaO2 / FiO2) at 6h, 12h, 24h
Time frame: at 6 hours, 12 hours, 24 hours of the PEP-OP test
Mechanical ventilation time
Time frame: Discharge from intensive care unit
Hospitalization in intensive care time
Time frame: Discharge from intensive care unit
The need for recourse to alternative therapies of oxygenation
Time frame: Discharge from intensive care unit
Incidence of barotrauma
Time frame: After PEP-OP
Pulmonary compliance at 6 hours, 12 hours and 24 hours
Time frame: at 6 hours, 12 hours and 24 hours of the PEP-OP test.
Results and safety
The study was stopped early (reason given: Technical difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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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.
Julien MARC, DR principal investigator
Hospital of Lens
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TITRATION in people with Respiratory Distress Syndrome, Adult, run by Centre Hospitalier de Lens at 4 sites 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 7 inclusion and 10 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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: Technical difficulties). 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?
oxygenation and pulmonary compliance (time frame: at 1 hours of the PEP-OP test.). 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 Mar 2021.