Clinical trial NCT01573481: Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning
Official title: Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning Failure
COPD Exacerbation
Keywords: WEANING
PRESSURE CONTROLLED CONTINOUS VENTILATION
PRESSURE VENTILATION SUPPORT
SLEEP
POLYGRAPHIC RECORD
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare pressure controlled continuous mandatory ventilation versus pressure support ventilation during the night for weaning to mechanical ventilation in chronic obstructive pulmonary disease patients and their impact onto sleep quality.


Eligibility criteria: Inclusion Criteria:

* The patient and/or legal representative of the patient has provided a written informed consent before inclusion in the study
* The patients is hospitalized in respiratory and critical care unit (university hospital of AMIENS, FRANCE)
* the patient is mechanically ventilated (ventilator model : puritan-bennett B840)
* Pulmonary disease,chronic obstructive (Spirometry and Blood Gas Analysis in chronic state before admission)
* stable cardiovascular status (cardiac frequency \< 140 beats/min and systolic blood pressure : 90-160 mmHg without catecholamines)
* midazolam \< 0,05mg/kg/h
* sufentanyl \< 0,05µ/kg/h
* the disorder that caused respiratory failure and prompted mechanical ventilation is treated
* the clinician suspects the patient may be ready to begin the weaning process
* inspiratory oxygen fraction (FiO2) \< 50%
* positive end-expiratory pressure \< or equal 8cmH2O
* during the day, the patient tolerate pressure support ventilation (pressure support level \< 15cmH2O
* respiratory frequency (FR) \< 35 breaths/min
* tidal volume (VT) \> 5ml/kg
* PaO2/FiO2 \> 200 mmHg
* FR/VT \< 105 breaths/min/L

Exclusion Criteria:

* sleep apnea, central
* narcolepsy
* Encephalopathy, Metabolic AND Encephalitis

Primary outcomes:
measure: Weaning duration
timeFrame: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)
Secondary outcomes:
measure: weaning failure
timeFrame: 48 hours
measure: Quantity and quality of sleep
timeFrame: 1 to 21 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: Pneumologie et Réanimation Respiratoire
Study officials:
affiliation: CHU Amiens
name: ANDREJAK Claire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: JOUNIEAUX Vincent, MD PhD
role: STUDY_DIRECTOR
affiliation: CHU Amiens
name: BASILLE Damien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: ROGER Pierre-Alexandre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: ROSE Dominique, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: MONCONDUIT Julien, MD
role: PRINCIPAL_INVESTIGATOR
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