Clinical Trials Directory

Trials / Completed

CompletedNCT01815034

Trancutaneous Monitoring to Avoid Hypercapnea During Complex Catheter Ablations

Transcutaneous Monitoring to Avoid Hypercapnea During Complex Catheter Ablations: a Joint Quality Initiative Pilot From Cardiac Electrophysiology and Anesthesiology

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
The Cleveland Clinic · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

Timeline

Start date
2013-03-01
Primary completion
2013-07-01
Completion
2013-07-01
First posted
2013-03-20
Last updated
2014-08-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01815034. Inclusion in this directory is not an endorsement.