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"VARIABLE-PSV" Study

Primary Purpose

Acute Respiratory Failure, Critical Illness, Ventilation Weaning

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
VARIABLE-PSV ventilatory mode
STANDARD-PSV ventilatory mode
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Acute respiratory failure, Critical illness, Mechanical ventilation, Ventilation weaning, Intensive Care Unit, Variable (NOISY) PSV, PSV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology & Critical Care, St Eloi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

VARIABLE-PSV ventilatory mode

STANDARD-PSV ventilatory mode

Arm Description

Outcomes

Primary Outcome Measures

Oxygenation in each ventilatory mode
We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.

Secondary Outcome Measures

Ventilatory comfort
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
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
Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation
Ventilatory effects
Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.
Sleep quality
Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation

Full Information

First Posted
April 18, 2012
Last Updated
May 28, 2013
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01580956
Brief Title
"VARIABLE-PSV" Study
Official Title
Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Critical Illness, Ventilation Weaning
Keywords
Acute respiratory failure, Critical illness, Mechanical ventilation, Ventilation weaning, Intensive Care Unit, Variable (NOISY) PSV, PSV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VARIABLE-PSV ventilatory mode
Arm Type
Other
Arm Title
STANDARD-PSV ventilatory mode
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
VARIABLE-PSV ventilatory mode
Intervention Description
The two ventilatory modes will be studied during 24h in intubated patients in random order.
Intervention Type
Other
Intervention Name(s)
STANDARD-PSV ventilatory mode
Intervention Description
The two ventilatory modes will be studied during 24h in intubated patients in random order.
Primary Outcome Measure Information:
Title
Oxygenation in each ventilatory mode
Description
We will performed arterial blood gases and oxygenation wil be evaluated by the PaO2/FiO2 ration.
Time Frame
after 24h of mechanical ventilation in each mode
Secondary Outcome Measure Information:
Title
Ventilatory comfort
Description
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.
Time Frame
during 24h in each mode
Title
Feasibility
Description
Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.
Time Frame
during the 24 hours
Title
Patient/ventilator asynchronism
Description
Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation
Time Frame
during the 24 hours
Title
Ventilatory effects
Description
Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.
Time Frame
during the 24 hours
Title
Sleep quality
Description
Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation
Time Frame
after the 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Anesthesiology & Critical Care, St Eloi University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

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