Respiratory Mechanics in Intensive Care Patients
PREMIER
Study of the Respiratory Mechanics Characteristics With Esophageal PREssure Measurements in Mechanically Ventilated Patients in IntensivE caRe Unit
1 other identifier
interventional
200
1 country
1
Brief Summary
This study aims at assessing the respiratory mechanics of intubated patients in intensive care unit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
March 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedMarch 30, 2018
February 1, 2018
10 months
January 18, 2018
March 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chest wall compliance measurement (mL/cmH2O)
1 hour
Secondary Outcomes (2)
lung compliance measurement (mL/cmH2O)
1 hour
End expiratory lung volume (mL)
1 hour
Study Arms (1)
Assessement of respiratory mechanics
EXPERIMENTALMeasurement of respiratory mechanics characteristics
Interventions
Use of a nasogastric tube equipped with esophageal balloon to assess respiratory mechanics
Eligibility Criteria
You may qualify if:
- Age \> or = 18 years
- Invasive mechanical ventilation on tracheal tube
- Treatment with neuromuscular blocking agents
- Nasogastric tube needed for enteral nutrition
You may not qualify if:
- Lack of free and informed consent
- Pregnant or breastfeeding woman
- Contra-indication to esophageal pressure measurement catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital
Angers, 49100, France
Related Publications (2)
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.
PMID: 37667379DERIVEDBeloncle 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.
PMID: 35579690DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
François Beloncle, MCU-PH
University Hospital, Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2018
First Posted
February 5, 2018
Study Start
March 28, 2018
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
March 30, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share