"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
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Failure
Critical Illness
Ventilation Weaning
Other: VARIABLE-PSV ventilatory mode
Other: STANDARD-PSV ventilatory mode
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
VARIABLE-PSV ventilatory mode Other: VARIABLE-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.
STANDARD-PSV ventilatory mode Other: STANDARD-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580956

Locations
France
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01580956     History of Changes
Other Study ID Numbers: UF 8897
Study First Received: April 18, 2012
Last Updated: May 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
Acute respiratory failure
Critical illness
Mechanical ventilation
Ventilation weaning
Intensive Care Unit
Variable (NOISY) PSV
PSV

Additional relevant MeSH terms:
Critical Illness
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on April 21, 2014