NCT01580956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

April 18, 2012

Last Update Submit

May 28, 2013

Conditions

Acute Respiratory FailureCritical IllnessVentilation Weaning

Keywords

Acute respiratory failureCritical illnessMechanical ventilationVentilation weaningIntensive Care UnitVariable (NOISY) PSVPSV

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

VARIABLE-PSV ventilatory mode

OTHER
Other: VARIABLE-PSV ventilatory mode

STANDARD-PSV ventilatory mode

OTHER
Other: STANDARD-PSV ventilatory mode

Interventions

VARIABLE-PSV ventilatory modeOTHER

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

VARIABLE-PSV ventilatory mode
STANDARD-PSV ventilatory modeOTHER

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

STANDARD-PSV ventilatory mode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical instability for any reason.
  • Life support withdrawal code
  • Patient under tutelage
  • Pregnancy
  • No French health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 19, 2012

Study Start

April 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 29, 2013

Record last verified: 2012-04

Locations

FR(1)