"VARIABLE-PSV" Study

This study is not yet open for participant recruitment.

Verified April 2012 by University Hospital, Montpellier

Sponsor:

Information provided by (Responsible Party):

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT01580956

First received: April 18, 2012

Last updated: April 20, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 18, 2012
Last Updated Date	April 20, 2012
Start Date ^ICMJE	April 2012
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 20, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: April 18, 2012)	Oxygenation in each ventilatory mode [ Time Frame: after 24h of mechanical ventilation in each mode ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT01580956 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 20, 2012)	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
Original Secondary Outcome Measures ^ICMJE (submitted: April 18, 2012)	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
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	"VARIABLE-PSV" Study
Official Title ^ICMJE	Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Acute Respiratory Failure Critical Illness Ventilation Weaning
Intervention ^ICMJE	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.
Study Arm (s)	VARIABLE-PSV ventilatory mode Intervention: Other: VARIABLE-PSV ventilatory mode STANDARD-PSV ventilatory mode Intervention: Other: STANDARD-PSV ventilatory mode
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	August 2012
Estimated Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01580956
Other Study ID Numbers ^ICMJE	UF 8897
Has Data Monitoring Committee	No
Responsible Party	University Hospital, Montpellier
Study Sponsor ^ICMJE	University Hospital, Montpellier
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Montpellier
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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