Trancutaneous Monitoring to Avoid Hypercapnea During Complex Catheter Ablations

NCT ID: NCT01815034

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-07-31

Brief Summary

Use of trancutaneous CO2 (TC02) monitoring to aide in titration of sedation of midazolam and fentanyl. Trancutaneous readings validated with invasively obtained specimens from existing arterial sheaths required during AF and VT ablations (trans-septal and retrograde aortic respectively)

Detailed Description

Cardiac electrophysiology procedures are typically performed under moderate (conscious) sedation in most centers. Advantages over general anesthesia include facilitating arrhythmia induction, avoidance of intubation and ventilator related complications and shorter post-procedure recovery times for most patients. However, the cumulative respiratory depressant effects of fentanyl and midazolam during prolonged procedures can rarely cause hypoventilation resulting in hypercapnea and respiratory failure. Complex catheter ablations for atrial fibrillation and ventricular tachycardia can exceed 3-5 hours in duration requiring large cumulative doses of midazolam and fentanyl. End tidal CO2 monitors, particularly in non-ventilated patients, have limitations and obtaining frequent arterial blood gas samples are often impractical. It remains unknown if contemporary trancutaneous CO2 monitoring (TCO2)can provide a feasible alternative to avoid over-sedation and resultant respiratory complications during complex catheter ablations with sufficient agreement to invasively obtained PCO2 data.

Conditions

Hypercapnia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing catheter ablation for atrial fibrillation (AF) or ventricular tachycardia (VT) under moderate sedation.

Exclusion Criteria

• Procedures scheduled for general anesthesia

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Dan Cantillon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J Cantillon, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

13-083

Identifier Type: -

Identifier Source: org_study_id