Respiratory Mechanics in Intensive Care Patients (PREMIER)

March 28, 2018 updated by: University Hospital, Angers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chest wall compliance measurement (mL/cmH2O)
Time Frame: 1 hour
1 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
lung compliance measurement (mL/cmH2O)
Time Frame: 1 hour
1 hour
End expiratory lung volume (mL)
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: François Beloncle, MCU-PH, University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

February 1, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 49RC17_0200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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