Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Oxygenation in NAVA and in PAV+
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
NAVA ventilatory mode
Intervention: NAVA ventilatory mode (Other)
PAV+ ventilatory mode
Intervention: PAV+ ventilatory mode (Other)
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+)