"VARIABLE-PSV" Study

Critical Illness Clinical Trial

Official title:

Evaluation a New Ventilatory Modes: VARIABLE-PSV: a Randomized Controlled Cross-over Study: the " VARIABLE-PSV" Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580956
• Other study ID #: UF 8897
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2012
• Last updated: May 28, 2013
• Start date: April 2012
• Est. completion date: August 2012

Study information

• Verified date: April 2012
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Critical Illness
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Ventilation Weaning

Intervention

Other:
• VARIABLE-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.
• STANDARD-PSV ventilatory mode
The two ventilatory modes will be studied during 24h in intubated patients in random order.

Locations

Country	Name	City	State
France	Department of Anesthesiology & Critical Care, St Eloi University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	during 24h in each mode	Yes
Secondary	Feasibility	Evaluation of time spent in each mode during the 24 hours of ventilation without any side effects and switch for another ventilatory mode.	during the 24 hours	Yes
Secondary	Patient/ventilator asynchronism	Evaluation of number of asynchrony evaluated by an Asynchrony Index (AI) in each mode during the 24 hours of mechanical ventilation	during the 24 hours	Yes
Secondary	Ventilatory effects	Evaluation of machine ventilatory behaviors in each mode during the 24 hours of mechanical ventilation.	during the 24 hours	Yes
Secondary	Sleep quality	Evaluation of quality of sleep in each mode after the 24h of mechanical ventilation	after the 24 hours	Yes