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

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Weaning Failure; COPD Exacerbation

Treatments: Other: Pressure controlled ventilation; Other: pressure support ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01573481

PI2012_843_0016

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Pressure support ventilation

Active Comparator group

Description:

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).

Treatment:

Other: pressure support ventilation

Pressure controlled ventilation

Active Comparator group

Description:

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).

Treatment:

Other: Pressure controlled ventilation