Intensive CarePREMIERNCT03420417
Respiratory Mechanics in Intensive Care Patients
A study testing Esophageal pressure measurement in people with Intensive Care and Ventilator Lung, run by University Hospital, Angers at 1 site in France.
Trial summary
This study aims at assessing the respiratory mechanics of intubated patients in intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care, Ventilator Lung
- What is being tested?
- Esophageal pressure measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2018to Feb 2019
- 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
- Age > or = 18 years
- Invasive mechanical ventilation on tracheal tube
- Treatment with neuromuscular blocking agents
- Nasogastric tube needed for enteral nutrition
Who cannot join
- Lack of free and informed consent
- Pregnant or breastfeeding woman
- Contra-indication to esophageal pressure measurement catheter
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital
Angers, 49100
BELONCLE François, MCU-PH, 0241353845, Francois.Beloncle@chu-angers.fr
About this study
Official title: Study of the Respiratory Mechanics Characteristics With Esophageal PREssure Measurements in Mechanically Ventilated Patients in IntensivE caRe Unit
This study aims at assessing the respiratory mechanics of intubated patients in intensive care unit.
- Conditions
- Intensive Care, Ventilator Lung
- Being tested
- Esophageal pressure measurement
- Keywords
- Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal pressure measurementDevice
Use of a nasogastric tube equipped with esophageal balloon to assess respiratory mechanics
| Study group | Role | What they receive |
|---|---|---|
| Assessement of respiratory mechanics | Experimental | Measurement of respiratory mechanics characteristics Receives: Device: Esophageal pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest wall compliance measurement (mL/cmH2O)
Measured: 1 hour
Secondary outcomes (2)
lung compliance measurement (mL/cmH2O)
Measured: 1 hour
End expiratory lung volume (mL)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start28 Mar 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- François Beloncle, MCU-PH, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420417
- Sponsor's protocol ID
- 49RC17_0200
- Acronym
- PREMIER
- Status last verified
- Feb 2018
- First submitted
- 18 Jan 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beloncle FM, Richard JC, Merdji H, Desprez C, Pavlovsky B, Yvin E, Piquilloud L, Olivier PY, Chean D, Studer A, Courtais A, Campfort M, Rahmani H, Lesimple A, Meziani F, Mercat A. Advanced respiratory mechanics assessment in mechanically ventilated obese and non-obese patients with or without acute respiratory distress syndrome. Crit Care. 2023 Sep 4;27(1):343. doi: 10.1186/s13054-023-04623-2.
PubMed 37667379Beloncle FM, Merdji H, Lesimple A, Pavlovsky B, Yvin E, Savary D, Mercat A, Meziani F, Richard JC. Gas Exchange and Respiratory Mechanics after a Cardiac Arrest: A Clinical Description of Cardiopulmonary Resuscitation-associated Lung Edema. Am J Respir Crit Care Med. 2022 Sep 1;206(5):637-640. doi: 10.1164/rccm.202111-2644LE. No abstract available.
PubMed 35579690
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Respiratory Mechanics Characteristics With Esophageal PREssure Measurements in Mechanically Ventilated Patients in IntensivE caRe Unit
- ClinicalTrials.gov ID
- NCT03420417
- Acronym / sponsor ID
- PREMIER / 49RC17_0200
- Conditions
- Intensive Care, Ventilator Lung
- Keywords
- Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 5 Feb 2018 (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 study aims at assessing the respiratory mechanics of intubated patients in intensive care unit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessement of respiratory mechanics | Experimental | Device: Esophageal pressure measurementMeasurement of respiratory mechanics characteristics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > or = 18 years
- Invasive mechanical ventilation on tracheal tube
- Treatment with neuromuscular blocking agents
- Nasogastric tube needed for enteral nutrition
Key exclusion criteria (3 listed)
- Lack of free and informed consent
- Pregnant or breastfeeding woman
- Contra-indication to esophageal pressure measurement catheter
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 |
|---|---|---|
| Esophageal pressure measurementUse of a nasogastric tube equipped with esophageal balloon to assess respiratory mechanics | Device | Assessement of respiratory mechanics |
Primary outcome
Chest wall compliance measurement (mL/cmH2O)
Time frame: 1 hour
2 secondary outcomes
lung compliance measurement (mL/cmH2O)
Time frame: 1 hour
End expiratory lung volume (mL)
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 37667379Beloncle FM, Richard JC, Merdji H, Desprez C, Pavlovsky B, Yvin E, Piquilloud L, Olivier PY, Chean D, Studer A, Courtais A, Campfort M, Rahmani H, Lesimple A, Meziani F, Mercat A. Advanced respiratory mechanics assessment in mechanically ventilated obese and non-obese patients with or without acute respiratory distress syndrome. Crit Care. 2023 Sep 4;27(1):343. doi: 10.1186/s13054-023-04623-2.
- Derived from this study: PubMed 35579690Beloncle FM, Merdji H, Lesimple A, Pavlovsky B, Yvin E, Savary D, Mercat A, Meziani F, Richard JC. Gas Exchange and Respiratory Mechanics after a Cardiac Arrest: A Clinical Description of Cardiopulmonary Resuscitation-associated Lung Edema. Am J Respir Crit Care Med. 2022 Sep 1;206(5):637-640. doi: 10.1164/rccm.202111-2644LE. No abstract available.
- Individual participant dataSharing planned: No
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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.
François Beloncle, MCU-PH principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal pressure measurement in people with Intensive Care and Ventilator Lung, run by University Hospital, Angers 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 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 30 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Beloncle, MCU-PH (0241353845, Francois.Beloncle@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest wall compliance measurement (mL/cmH2O) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420417, which also lists 2 linked publications.
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 30 Mar 2018.