"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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Acute Respiratory Failure; Ventilation Weaning
• Intervention / Treatment: Other: VARIABLE-PSV ventilatory mode; Other: STANDARD-PSV ventilatory mode

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VARIABLE-PSV ventilatory mode	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	Other: STANDARD-PSV ventilatory mode; The two ventilatory modes will be studied during 24h in intubated patients in random order.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation in each ventilatory mode	We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.	after 24h of mechanical ventilation in each mode

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilatory comfort	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.	during 24h in each mode
Feasibility	Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.	during the 24 hours
Patient/ventilator asynchronism	Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation	during the 24 hours
Ventilatory effects	Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.	during the 24 hours
Sleep quality	Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation	after the 24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Critical illness; Mechanical ventilation; Acute respiratory failure; PSV; Ventilation weaning; Variable (NOISY) PSV
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: UF 8897