Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases (REVENTIL 2)

C

Centre Hospitalier Universitaire, Amiens

Status

Withdrawn

Conditions

Noctural Ventilatory Mode and Weaning Duration

Treatments

Procedure: Nocturnal controlled pressure control ventilation
Procedure: Pressure support ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT03428737
PI2017_843_0016

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Nocturnal controlled pressure control ventilation
Other group
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
Treatment:
Procedure: Nocturnal controlled pressure control ventilation
Nocturnal pressure support ventilation
Other group
Description:
Use of a pressure support level identical during the night to the pressure support level at the end of the day.
Treatment:
Procedure: Pressure support ventilation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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