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

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040675
• Other study ID #: TCH01
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: March 28, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: ProMedica Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac arrhythmia

Exclusion Criteria:

• Pregnancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Locations

Country	Name	City	State
United States	Promedica Toledo Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ProMedica Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types of cardiac arrhythmia		1 year	No