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

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ClinicalTrials.gov Identifier: NCT03428737
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Noctural Ventilatory Mode and Weaning Duration Procedure: Nocturnal controlled pressure control ventilation Procedure: Pressure support ventilation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Nocturnal Pressure Controlled Ventilation on Mechanical Ventilation Weaning Duration in Patients With Chronic Obstructive Respiratory Diseases REVENTIL 2
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
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
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

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.
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.




Primary Outcome Measures :
  1. The percentage of ventilation weaning at Day 4 [ Time Frame: at 4 day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428737


Contacts
Contact: Claire ANDREJAK, Professor +33 3 22 08 78 93 andrejak.claire@chu-amiens.fr

Locations
France
Chu Amiens Recruiting
Amiens, France, 80054
Contact: Claire ANDREJAK, Professor    +33 3 22 08 78 93    andrejak.claire@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03428737     History of Changes
Other Study ID Numbers: PI2017_843_0016
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
pressure support ventilation
pressure control ventilation
sleep, weaning
chronic obstructive respiratory disease
weaning duration period

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases