"VARIABLE-PSV" Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Respiratory Failure Critical Illness Ventilation Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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VARIABLE-PSV ventilatory mode

Group Type OTHER

VARIABLE-PSV ventilatory mode

Intervention Type OTHER

The two ventilatory modes will be studied during 24h in intubated patients in random order.

STANDARD-PSV ventilatory mode

Group Type OTHER

STANDARD-PSV ventilatory mode

Intervention Type OTHER

The two ventilatory modes will be studied during 24h in intubated patients in random order.

Interventions

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VARIABLE-PSV ventilatory mode

The two ventilatory modes will be studied during 24h in intubated patients in random order.

Intervention Type OTHER

STANDARD-PSV ventilatory mode

The two ventilatory modes will be studied during 24h in intubated patients in random order.

Intervention Type OTHER

Eligibility Criteria

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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