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Completed

NCT Number: NCT01580956

"VARIABLE-PSV" Study

Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.

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Key information

Conditions

Acute Respiratory Failure Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Ventilation Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

About this study

Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ventilation planned for more than 48 h
  • patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0
  • Age > or equal 18
  • Surrogate decision maker's consent

Exclusion criteria

  • Clinical instability for any reason.
  • Life support withdrawal code
  • Patient under tutelage
  • Pregnancy
  • No French health insurance

Treatment and study plan

VARIABLE-PSV ventilatory mode

Other

The two ventilatory modes will be studied during 24h in intubated patients in random order.

STANDARD-PSV ventilatory mode

Other

The two ventilatory modes will be studied during 24h in intubated patients in random order.

Primary outcomes

  1. Oxygenation in each ventilatory mode

    Time frame: after 24h of mechanical ventilation in each mode

    We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.

Secondary outcomes

  1. Ventilatory comfort

    Time frame: during 24h in each mode

    Comfort zone is defined as previously reported in some papers as considered adequate ventilation : 6 < tidal volume < 10 ml/kg, ETCO2 < 55 mmHg and < 65 mmHg for COPD patients and 12 < Respiratory rate < 35 cycles/min.

  2. Feasibility

    Time frame: during the 24 hours

    Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.

  3. Patient/ventilator asynchronism

    Time frame: during the 24 hours

    Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation

  4. Ventilatory effects

    Time frame: during the 24 hours

    Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.

  5. Sleep quality

    Time frame: after the 24 hours

    Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2012
Registry last updated
May 29, 2013

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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