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NCT03420417 Clinical Trial

Respiratory Mechanics in Intensive Care Patients

Intensive Care Clinical Trial

— PREMIER  

Official title:
Study of the Respiratory Mechanics Characteristics With Esophageal PREssure Measurements in Mechanically Ventilated Patients in IntensivE caRe Unit

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03420417
Other study ID # 49RC17_0200
Secondary ID
Status Recruiting
Phase N/A
First received January 18, 2018
Last updated March 28, 2018
Start date March 28, 2018
Est. completion date February 2019

Study information
Verified date February 2018
Source University Hospital, Angers
Contact François Beloncle, MCU-PH
Phone 0241353845
Email Francois.Beloncle@chu-angers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims at assessing the respiratory mechanics of intubated patients in intensive care unit.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Esophageal pressure measurement
Use of a nasogastric tube equipped with esophageal balloon to assess respiratory mechanics

Locations
Country Name City State
France University hospital Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Chest wall compliance measurement (mL/cmH2O) 1 hour
Secondary lung compliance measurement (mL/cmH2O) 1 hour
Secondary End expiratory lung volume (mL) 1 hour
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