Evaluation of Synchrony in the Post-operative Patient

NCT ID: NCT01771341

Last Updated: 2015-01-22

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-12-31

Brief Summary

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Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.

Detailed Description

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Conditions

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Patient-ventilator Asynchronism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pressure support

Group Type PLACEBO_COMPARATOR

MAQUET SERVOi ventilator

Intervention Type DEVICE

Pressure Support

NAVA

Group Type EXPERIMENTAL

MAQUET SERVOi ventilator with Edi Catheter

Intervention Type DEVICE

NAVA respiratory modality

Interventions

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MAQUET SERVOi ventilator with Edi Catheter

NAVA respiratory modality

Intervention Type DEVICE

MAQUET SERVOi ventilator

Pressure Support

Intervention Type DEVICE

Other Intervention Names

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Neurally Adjusted Ventilatory Assist Pressure Support

Eligibility Criteria

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Inclusion Criteria

* adult \> 18 yr-old
* abdominal post-operative patient
* able to trigger the ventilator

Exclusion Criteria

* infant
* pregnancy
* esophageal surgery
* recent esophageal variceal bleeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent WALLET, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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2010.646

Identifier Type: -

Identifier Source: org_study_id

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