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

Phase 3

Completed

• Conditions: Intensive Care; Critical Illness; Mechanical Ventilation; Ventilation Weaning
• Interventions: Other: PAV+ ventilatory mode; Other: NAVA ventilatory mode

• Registration Number: NCT01607723
• Lead Sponsor: University Hospital, Montpellier

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 Timeline

• Study First Submitted: 2012-04-18
• Study Start: 2012-05
• Primary Completion: 2012-05
• Study First Submitted QC: 2012-05-24
• Study First Posted: 2012-05-30
• Study Completion: 2014-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PAV+ ventilatory mode	PAV+ ventilatory mode	-
NAVA ventilatory mode	NAVA ventilatory mode	-

Primary Outcome Measures

Name	Time	Method
Oxygenation in NAVA and in PAV+	after one day of ventilation in NAVA and in PAV+

Secondary Outcome Measures

Name	Time	Method
Ventilatory comfort	Every 6 hours in the two ventilatory modes	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.
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+	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.
Ventilatory parameters	During the 24h of mechanical ventilation in NAVA and in PAV+	The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).

Trial Locations

Locations (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital; 🇫🇷 Montpellier, France