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

NCT ID: NCT03428737

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Noctural Ventilatory Mode and Weaning Duration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Nocturnal controlled pressure control ventilation

Intervention Type 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 pressure support ventilation

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

Group Type OTHER

Pressure support ventilation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Pressure support ventilation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2017_843_0016

Identifier Type: -

Identifier Source: org_study_id

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