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

Not Applicable

Completed

• Conditions: Weaning Failure; COPD Exacerbation
• Interventions: Other: Pressure controlled ventilation; Other: pressure support ventilation

• Registration Number: NCT01573481
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-09
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure controlled ventilation	Pressure controlled ventilation	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).
Pressure support ventilation	pressure support ventilation	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
weaning failure	48 hours	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
Quantity and quality of sleep	1 to 21 days	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.

Trial Locations

Locations (1)

Pneumologie et Réanimation Respiratoire; 🇫🇷 Amiens, France