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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT01607723

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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+.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Mechanical Ventilation Intensive Care Ventilation Weaning	Other: NAVA ventilatory mode Other: PAV+ ventilatory mode	Phase 3

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

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: NAVA ventilatory mode	Other: NAVA ventilatory mode The two ventilatory modes will be studied during 24h in intubated patients in random order.
Other: PAV+ ventilatory mode	Other: PAV+ ventilatory mode The two ventilatory modes will be studied during 24h in intubated patients in random order.

Arm

Intervention/Treatment

Other: NAVA ventilatory mode

Other: NAVA ventilatory mode

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

Other: PAV+ ventilatory mode

Other: PAV+ ventilatory mode

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

Outcome Measures

Primary Outcome Measures

Oxygenation in NAVA and in PAV+ [after one day of ventilation in NAVA and in PAV+]

Secondary Outcome Measures

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.
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).
Sleep pattern [During 24h of mechanical ventilation in NAVA and in PAV+]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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