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"VARIABLE-PSV" Study

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status and phase

Completed
Phase 3

Conditions

Ventilation Weaning
Critical Illness
Acute Respiratory Failure

Treatments

Other: STANDARD-PSV ventilatory mode
Other: VARIABLE-PSV ventilatory mode

Study type

Interventional

Funder types

Other

Identifiers

NCT01580956
UF 8897

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

VARIABLE-PSV ventilatory mode
Other group
Treatment:
Other: VARIABLE-PSV ventilatory mode
STANDARD-PSV ventilatory mode
Other group
Treatment:
Other: STANDARD-PSV ventilatory mode

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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