Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study

University Hospital, Montpellier1 site in 1 country13 target enrollmentMay 2012

ConditionsCritical Illness Mechanical Ventilation Intensive Care Ventilation Weaning

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Critical Illness
Sponsor: University Hospital, Montpellier
Enrollment: 13
Locations: 1
Primary Endpoint: Oxygenation in NAVA and in PAV+
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.

Detailed Description

Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

March 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Estimated remaining duration of mechanical ventilation for more than two days
•patient alert and calm
•Surrogate decision maker's consent

Exclusion Criteria

•Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
•Clinical instability for any reason
•Contraindications for continuing intensive care treatment
•Patient under tutelage
•Age \< 18 years
•Pregnancy
•No French health insurance

Outcomes

Primary Outcomes

Oxygenation in NAVA and in PAV+

Time Frame: after one day of ventilation in NAVA and in PAV+

Secondary Outcomes

Ventilatory comfort(Every 6 hours in the two ventilatory modes)
Sleep pattern(During 24h of mechanical ventilation in NAVA and in PAV+)
Patient-ventilator asynchronies(During the 24h of mechanical ventilation in NAVA and in PAV+)
Ventilatory parameters(During the 24h of mechanical ventilation in NAVA and in PAV+)