PREMIER: Respiratory Mechanics in Intensive Care Patients
Sponsor
University Hospital, Angers (Other)
Overall Status
Unknown status
CT.gov ID
NCT03420417
Collaborator
(none)
200
1
1
10.2
19.6
Study Details
Study Description
Brief Summary
This study aims at assessing the respiratory mechanics of intubated patients in intensive care unit.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study of the Respiratory Mechanics Characteristics With Esophageal PREssure Measurements in Mechanically Ventilated Patients in IntensivE caRe Unit
Actual Study Start Date
:
Mar 28, 2018
Anticipated Primary Completion Date
:
Feb 1, 2019
Anticipated Study Completion Date
:
Feb 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Assessement of respiratory mechanics Measurement of respiratory mechanics characteristics |
Device: Esophageal pressure measurement
Use of a nasogastric tube equipped with esophageal balloon to assess respiratory mechanics
|
Outcome Measures
Primary Outcome Measures
- Chest wall compliance measurement (mL/cmH2O) [1 hour]
Secondary Outcome Measures
- lung compliance measurement (mL/cmH2O) [1 hour]
- End expiratory lung volume (mL) [1 hour]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age > or = 18 years
-
Invasive mechanical ventilation on tracheal tube
-
Treatment with neuromuscular blocking agents
-
Nasogastric tube needed for enteral nutrition
Exclusion Criteria:
-
Lack of free and informed consent
-
Pregnant or breastfeeding woman
-
Contra-indication to esophageal pressure measurement catheter
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital | Angers | France | 49100 |
Sponsors and Collaborators
- University Hospital, Angers
Investigators
- Principal Investigator: François Beloncle, MCU-PH, University Hospital, Angers
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT03420417
Other Study ID Numbers:
- 49RC17_0200
First Posted:
Feb 5, 2018
Last Update Posted:
Mar 30, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Angers