"VARIABLE-PSV" Study

Phase 3

Completed

• Conditions: Acute Respiratory Failure; Critical Illness; Ventilation Weaning
• Interventions: Other: VARIABLE-PSV ventilatory mode; Other: STANDARD-PSV ventilatory mode

• Registration Number: NCT01580956
• Lead Sponsor: University Hospital, Montpellier

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 Timeline

• Status Verified: 2012-04
• Study Start: 2012-04
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VARIABLE-PSV ventilatory mode	VARIABLE-PSV ventilatory mode	-
STANDARD-PSV ventilatory mode	STANDARD-PSV ventilatory mode	-

Primary Outcome Measures

Name	Time	Method
Oxygenation in each ventilatory mode	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

Name	Time	Method
Ventilatory comfort	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.
Feasibility	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.
Patient/ventilator asynchronism	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
Ventilatory effects	during the 24 hours	Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.
Sleep quality	after the 24 hours	Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation

Trial Locations

Locations (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital; 🇫🇷 Montpellier, France