Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning

Study Overview
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Brief Summary
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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.

Official Title
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Pressure Controlled Ventilation Versus Pressure Support Ventilation During the Night: New Strategy of Mechanical Ventilation Weaning?

Conditions
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Weaning Failure, COPD Exacerbation

Intervention / Treatment
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* Other: pressure support ventilation
* Other: Pressure controlled ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pressure support ventilation<br>Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure support ventilation mode. The level of the pressure support is the same as the previous day. During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased). | Other: pressure support ventilation<br>* Patients in this group are ventilated during the night with pressure support ventilation mode. The level of the pressure support is the same as the previous day.<br>|
| Active Comparator: Pressure controlled ventilation<br>Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min). During the day (9 AM to 10 PM), patients are ventilated with pressure support ventilation (the level of pressure support is progressively decreased). | Other: Pressure controlled ventilation<br>* Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning duration | weaning duration in days (from the first day with spontaneous ventilation to extubation) | between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weaning failure | Failure of weaning = re-intubation, necessity of non invative ventilation support for periods during the day time or death, in the first 48 hours following extubation | 48 hours | 
| Quantity and quality of sleep | Polygraphic datas will be analyzed during weaning, integrating: Proportion of sleep stages (I, II, III, IV, REM sleep), overall sleep and awakeness period. Average ratio of diurnal sleep on total overall sleep, average ratio of diurnal sleep on total sleep at the first day of weaning and the day before extubation; Observation of central apneas from begining of weaning to extubation. | 1 to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WEANING, PRESSURE CONTROLLED CONTINOUS VENTILATION, PRESSURE VENTILATION SUPPORT, SLEEP, POLYGRAPHIC RECORD