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Completed

NCT Number: NCT01573481

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

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.

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Key information

Conditions

Weaning Failure COPD Exacerbation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pneumologie et Réanimation Respiratoire

Amiens, 80000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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).

Primary outcomes

  1. Weaning duration

    Time frame: 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 outcomes

  1. weaning failure

    Time frame: 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

  2. Quantity and quality of sleep

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: REVENTIL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2012
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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