ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases (REVENTIL 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03428737
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

The weaning of mechanical ventilation is difficult period. This period is particularly difficult for patient with obstructive chronic respiratory disease and a long mechanical ventilation is associated with an increased risk of infectious complication, cardiac dysfunction, muscular weakness or barotromatism. No guideline is available on the ventilator mode to use during the night. In weaning period, some studies have demonstrated that nocturnal control ventilation during the weaning period improved the quality and the quantity of sleep. The hypothesis is that use of nocturnal controlled mechanical ventilation could decrease the weaning period duration and the ventilation weaning failure because of a sleep improvement.

The main objective is to compare mechanical ventilation weaning period duration according to the nocturnal ventilator mode (pressure controlled ventilation versus pressure support ventilation) in patients with an obstructive respiratory disease. A secondary objective is to evaluate the rate of weaning failure after the first extubation according to the nocturnal ventilator mode and to evaluate the sleep during the weaning period according to the nocturnal ventilator mode.


Condition or disease Intervention/treatment Phase
Nocturnal Ventilatory Mode and Weaning Duration Procedure: For the group "nocturnal pressure controlled ventilation" Procedure: For the group "pressure support ventilation" Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases REVENTIL 2
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : September 9, 2018
Estimated Study Completion Date : January 4, 2019

Arm Intervention/treatment
First arm : nocturnal controlled pressure control ventilation.
use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night
Procedure: For the group "nocturnal pressure controlled ventilation"
use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night

Second arm : nocturnal pressure support ventilation.
use of a pressure support level identical during the night to the pressure support level at the end of the day.
Procedure: For the group "pressure support ventilation"
use of a pressure support level identical during the night to the pressure support level at the end of the day.




Primary Outcome Measures :
  1. The percentage of ventilation weaning at Day 4 [ Time Frame: at 4 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Patient with invasive mechanical ventilation (with B840 ventilator)
  • Patient with ventilation weaning criteria
  • Patient able to support during the day pressure support ventilation with pressure support lower than 19 cm of H2O.
  • Patient with all mechanical ventilation weaning criteria for the first trial of spontaneous ventilation.
  • Age > 18 years
  • Exclusion criteria: patient with central apnoea syndrome, patient with narcolepsy, patient with metabolic encephalopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428737


Contacts
Contact: Claire ANDREJAK, Professor +33 3 22 08 78 93 andrejak.claire@chu-amiens.fr

Locations
France
Chu Amiens Recruiting
Amiens, France, 80054
Contact: Claire ANDREJAK, Professor    +33 3 22 08 78 93    andrejak.claire@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03428737     History of Changes
Other Study ID Numbers: PI2017_843_0016
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
: pressure support ventilation, pressure control ventilation, sleep, weaning, chronic obstructive respiratory disease, weaning duration period

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases