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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness, Mechanical Ventilation, Intensive Care, Ventilation Weaning

Intervention / Treatment
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* Other: NAVA ventilatory mode
* Other: PAV+ ventilatory mode


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NAVA ventilatory mode<br> | Other: NAVA ventilatory mode<br>* The two ventilatory modes will be studied during 24h in intubated patients in random order.<br>|
| Other: PAV+ ventilatory mode<br> | Other: PAV+ ventilatory mode<br>* The two ventilatory modes will be studied during 24h in intubated patients in random order.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation in NAVA and in PAV+ |  | after one day of ventilation in NAVA and in PAV+ | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | During the 24h of mechanical ventilation in NAVA and in PAV+ | 
| Sleep pattern |  | During 24h of mechanical ventilation in NAVA and in PAV+ | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep pattern, Mechanical ventilation, weaning, Intensive Care, NAVA (Neurally Adjusted Ventilatory Assist), PAV+ (Proportional Assist Ventilation Plus)