Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases (REVENTIL 2)
Primary Purpose
Noctural Ventilatory Mode and Weaning Duration
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nocturnal controlled pressure control ventilation
Pressure support ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Noctural Ventilatory Mode and Weaning Duration focused on measuring pressure support ventilation, pressure control ventilation, sleep, weaning, chronic obstructive respiratory disease, weaning duration period
Eligibility Criteria
Inclusion 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.
Sites / Locations
- Chu Amiens
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Nocturnal controlled pressure control ventilation
Nocturnal pressure support ventilation
Arm Description
use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night
Use of a pressure support level identical during the night to the pressure support level at the end of the day.
Outcomes
Primary Outcome Measures
The percentage of ventilation weaning at Day 4
Secondary Outcome Measures
Full Information
NCT ID
NCT03428737
First Posted
February 5, 2018
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03428737
Brief Title
Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases
Acronym
REVENTIL 2
Official Title
Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases REVENTIL 2
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
none participant included
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
All patients with weaning criteria, spontaneous breathing test will be done. If patient is able to have spontaneous ventilation with maximum of 16 cm of H2O of pressure support, he could be included in the study. The nocturnal ventilation mode will be randomised between pressure controlled ventilation and pressure support ventilation with the same pressure support than during the day. We will follow the quality and quantity of sleep with continue polysomnography. Indeed, patients in ICU could sleep during the night but too during the day. We will compare the duration of the weaning period between the two arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noctural Ventilatory Mode and Weaning Duration
Keywords
pressure support ventilation, pressure control ventilation, sleep, weaning, chronic obstructive respiratory disease, weaning duration period
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nocturnal controlled pressure control ventilation
Arm Type
Other
Arm Description
use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night
Arm Title
Nocturnal pressure support ventilation
Arm Type
Other
Arm Description
Use of a pressure support level identical during the night to the pressure support level at the end of the day.
Intervention Type
Procedure
Intervention Name(s)
Nocturnal controlled pressure control ventilation
Intervention Description
use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night
Intervention Type
Procedure
Intervention Name(s)
Pressure support ventilation
Intervention Description
use of a pressure support level identical during the night to the pressure support level at the end of the day.
Primary Outcome Measure Information:
Title
The percentage of ventilation weaning at Day 4
Time Frame
at 4 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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.
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases
We'll reach out to this number within 24 hrs