"VARIABLE-PSV" Study

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acute Respiratory Failure; Critical Illness; Ventilation Weaning	Other: VARIABLE-PSV ventilatory mode; Other: STANDARD-PSV ventilatory mode	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
Study Start Date :	April 2012
Actual Primary Completion Date :	August 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, France, 34000

Sponsors and Collaborators

University Hospital, Montpellier

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT01580956 History of Changes
Other Study ID Numbers:	UF 8897
First Posted:	April 19, 2012
Last Update Posted:	May 29, 2013
Last Verified:	April 2012

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:

Respiratory Insufficiency; Critical Illness; Respiratory Distress Syndrome, Adult; Respiration Disorders	Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Lung Diseases