Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist)

NCT ID: NCT03027713

Last Updated: 2017-01-23

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients

Detailed Description

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We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups

Conditions

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Postoperative Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NAVA group with a specific catheter

The patients were allocated in the NAVA weaning protocol group

Group Type OTHER

weaning protocol

Intervention Type PROCEDURE

The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group

PSV group without a specific catheter

The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group

Group Type OTHER

weaning protocol

Intervention Type PROCEDURE

The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group

Interventions

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weaning protocol

The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated.

Exclusion Criteria

* Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role lead

Responsible Party

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F Javier Belda

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mar Garzando Civera, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fundación para la investigación del Hospital Clínico Universitario de Valencia

Other Identifiers

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dawNAVA

Identifier Type: -

Identifier Source: org_study_id

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