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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by ProMedica Health System
Sponsor:
Information provided by (Responsible Party):
Howard Stein, ProMedica Health System
ClinicalTrials.gov Identifier:
NCT02040675
First received: January 13, 2014
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition
Cardiac Arrhythmia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias

Resource links provided by NLM:


Further study details as provided by ProMedica Health System:

Primary Outcome Measures:
  • Types of cardiac arrhythmia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Cardiac arrhythmia

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02040675

Contacts
Contact: Howard Stein, MD 419 291-4225 howardstein@bex.net

Locations
United States, Ohio
Promedica Toledo Hospital Not yet recruiting
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
ProMedica Health System
Investigators
Principal Investigator: Howard Stein, MD Promedica Toledo CHildren's Hospital
  More Information

No publications provided

Responsible Party: Howard Stein, Director Neonatology, ProMedica Health System
ClinicalTrials.gov Identifier: NCT02040675     History of Changes
Other Study ID Numbers: TCH01
Study First Received: January 13, 2014
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014