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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Howard Stein, ProMedica Health System
ClinicalTrials.gov Identifier:
NCT02040675
First received: January 13, 2014
Last updated: March 28, 2016
Last verified: March 2016
  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 ]

Enrollment: 5
Study Start Date: February 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (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   (Adult, Senior)
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

Locations
United States, Ohio
Promedica Toledo Hospital
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
ProMedica Health System
Investigators
Principal Investigator: Howard Stein, MD Promedica Toledo CHildren's Hospital
  More Information

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: March 28, 2016
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 August 25, 2016