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

Noctural Ventilatory Mode and Weaning Duration Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03428737
• Other study ID #: PI2017_843_0016
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Noctural Ventilatory Mode and Weaning Duration
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Procedure:
• 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
• Pressure support ventilation
use of a pressure support level identical during the night to the pressure support level at the end of the day.

Locations

Country	Name	City	State
France	Chu Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of ventilation weaning at Day 4		at 4 day