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

NCT01573481 | Completed

• 1 other identifier: PI2012_843_0016
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning Failure; COPD Exacerbation

Keywords

WEANING; PRESSURE CONTROLLED CONTINOUS VENTILATION; PRESSURE VENTILATION SUPPORT; SLEEP; POLYGRAPHIC RECORD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• weaning failure

  48 hours

• Quantity and quality of sleep

  1 to 21 days

Study Arms (2)

Pressure support ventilation

ACTIVE COMPARATOR

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

Pressure controlled ventilation

ACTIVE COMPARATOR

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

Interventions

pressure support ventilation OTHER

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.

Pressure support ventilation

Pressure controlled ventilation OTHER

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).

Pressure controlled ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Pneumologie et Réanimation Respiratoire

Amiens, 80000, France

Location

Related Publications (23)

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  PMID: 23391488 RESULT

Study Officials

• ANDREJAK Claire, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• JOUNIEAUX Vincent, MD PhD

  CHU Amiens

  STUDY DIRECTOR

• BASILLE Damien, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• ROGER Pierre-Alexandre, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• ROSE Dominique, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• MONCONDUIT Julien, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: April 9, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)