Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute Respiratory Failure
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Oxygenation in each ventilatory mode
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- Ventilatory comfort(during 24h in each mode)
- Feasibility(during the 24 hours)
- Patient/ventilator asynchronism(during the 24 hours)
- Ventilatory effects(during the 24 hours)
- Sleep quality(after the 24 hours)