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

NCT03428737 | Withdrawn

• 1 other identifier: PI2017_843_0016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Noctural Ventilatory Mode and Weaning Duration

Keywords

pressure support ventilation; pressure control ventilation; sleep, weaning; chronic obstructive respiratory disease; weaning duration period

Outcome Measures

Primary Outcomes (1)

• The percentage of ventilation weaning at Day 4

  at 4 day

Study Arms (2)

Nocturnal controlled pressure control ventilation

OTHER

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: Nocturnal controlled pressure control ventilation

Nocturnal pressure support ventilation

OTHER

Use of a pressure support level identical during the night to the pressure support level at the end of the day.

Procedure: Pressure support ventilation

Interventions

Nocturnal controlled pressure control ventilation PROCEDURE

use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night

Nocturnal controlled pressure control ventilation

Pressure support ventilation PROCEDURE

use of a pressure support level identical during the night to the pressure support level at the end of the day.

Nocturnal pressure support ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with central apnoea syndrome
• Patient with narcolepsy
• Patient with metabolic encephalopathy.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Chu Amiens

Amiens, 80054, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: March 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

FR (1)