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

NCT ID: NCT01607723

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-03-31

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.

Conditions

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Critical Illness Mechanical Ventilation Intensive Care Ventilation Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NAVA ventilatory mode

Group Type OTHER

NAVA ventilatory mode

Intervention Type OTHER

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

PAV+ ventilatory mode

Group Type OTHER

PAV+ ventilatory mode

Intervention Type OTHER

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

Interventions

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NAVA ventilatory mode

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

Intervention Type OTHER

PAV+ ventilatory mode

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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UF 8916

Identifier Type: -

Identifier Source: org_study_id