"VARIABLE-PSV" Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01580956
First received: April 18, 2012
Last updated: May 28, 2013
Last verified: April 2012

April 18, 2012
May 28, 2013
April 2012
August 2012   (final data collection date for primary outcome measure)
Oxygenation in each ventilatory mode [ Time Frame: after 24h of mechanical ventilation in each mode ] [ Designated as safety issue: Yes ]
We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.
Oxygenation in each ventilatory mode [ Time Frame: after 24h of mechanical ventilation in each mode ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01580956 on ClinicalTrials.gov Archive Site
  • Ventilatory comfort [ Time Frame: during 24h in each mode ] [ Designated as safety issue: Yes ]
    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.
  • Feasibility [ Time Frame: during the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.
  • Patient/ventilator asynchronism [ Time Frame: during the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation
  • Ventilatory effects [ Time Frame: during the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.
  • Sleep quality [ Time Frame: after the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation
  • Ventilatory comfort [ Time Frame: during 24h in each mode ] [ Designated as safety issue: Yes ]
  • Feasibility [ Time Frame: during the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.
  • Patient/ventilator asynchronism [ Time Frame: during the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation
  • Ventilatory effects [ Time Frame: during the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of patient and machine ventilatory behaviours in each mode during the 24 hours of mechanical ventilation
  • Sleep quality [ Time Frame: after the 24 hours ] [ Designated as safety issue: Yes ]
    Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation
Not Provided
Not Provided
 
"VARIABLE-PSV" Study
Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Acute Respiratory Failure
  • Critical Illness
  • Ventilation Weaning
  • Other: VARIABLE-PSV ventilatory mode
    The two ventilatory modes will be studied during 24h in intubated patients in random order.
  • Other: STANDARD-PSV ventilatory mode
    The two ventilatory modes will be studied during 24h in intubated patients in random order.
  • VARIABLE-PSV ventilatory mode
    Intervention: Other: VARIABLE-PSV ventilatory mode
  • STANDARD-PSV ventilatory mode
    Intervention: Other: STANDARD-PSV ventilatory mode
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01580956
UF 8897
No
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Not Provided
University Hospital, Montpellier
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP