"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes

University Hospital, Montpellier13 enrolled

Overview

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+.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Critical Illness Mechanical Ventilation Intensive Care Ventilation Weaning

Interventions

NAVA ventilatory modeOTHER

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

PAV+ ventilatory modeOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, France

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

Ventilatory comfort will be assessed by : * objective criteria expressed in time spent in each mode in the area called "comfort" (12 \< Respiratory frequence \< 28 c/min ; Current Volume \> 300 mL and EtCO2 \< 55 mmHg) * subjective criteria expressed by the self-assessment of the patient's comfort on a visual analogic scale.

Time frame: Every 6 hours in the two ventilatory modes

Patient-ventilator asynchronies

The patient-ventilator asynchronies will be assessed by the asynchronie index (number of asynchronies / number of respiratory cycles). The number of asynchronies will be assessed by the investigator, on the records of the pression curves and the respirator outputs.

Time frame: During the 24h of mechanical ventilation in NAVA and in PAV+

Ventilatory parameters

The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).

Time frame: During the 24h of mechanical ventilation in NAVA and in PAV+

Sleep pattern

Time frame: During 24h of mechanical ventilation in NAVA and in PAV+

Data from ClinicalTrials.gov

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