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

Not Applicable

Withdrawn

• Conditions: Noctural Ventilatory Mode and Weaning Duration
• Interventions: Procedure: Nocturnal controlled pressure control ventilation; Procedure: Pressure support ventilation

• Registration Number: NCT03428737
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Study Start: 2019-03-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nocturnal controlled pressure control ventilation	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
Nocturnal pressure support ventilation	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

Name	Time	Method
The percentage of ventilation weaning at Day 4	at 4 day

Trial Locations

Locations (1)

Chu Amiens; 🇫🇷 Amiens, France