Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias

NCT ID: NCT02040675

Last Updated: 2016-03-29

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

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place.

Detailed Description

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The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital.

After the patient has been successfully intubated at the beginning of the procedure, a trained nurse, using standard technique for placement of a oro/nasogastric tube, will place an appropriately sized NAVA catheter in the patient. The lumen of the NAVA tube can be used as a conventional oro/nasogastric tube and the electrodes will be connected to the Servo-I ventilator. Although the Servo-I is a ventilator, it will be used only as a monitor for this study. The position of the nasogastric tube will then be refined using the catheter positioning screen as needed.

During the course of the EPSA various arrhythmias may become evident. When these are noted, screen shots will be saved on the Servo-i monitor. Surface and electrogram recordings will be saved at the same time. The NAVA catheter will be disconnected from the Servo-I monitor during the ablation part of the procedure to prevent inadvertent damage to the monitor.

Conditions

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Cardiac Arrhythmia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Cardiac arrhythmia

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ProMedica Health System

OTHER

Sponsor Role lead

Responsible Party

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Howard Stein

Director Neonatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Howard Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Promedica Toledo CHildren's Hospital

Locations

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Promedica Toledo Hospital

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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TCH01

Identifier Type: -

Identifier Source: org_study_id

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