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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Withdrawn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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 5, 2018
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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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

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