Clinical Trials Logo
  1. Home
  2. Hypercapnia
  3. NCT01815034
  4. Details
NCT01815034 Clinical Trial

Trancutaneous Monitoring to Avoid Hypercapnea During Complex Catheter Ablations

Hypercapnia Clinical Trial

— TCO2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01815034
Other study ID # 13-083
Secondary ID
Status Completed
Phase N/A
First received March 12, 2013
Last updated August 18, 2014
Start date March 2013
Est. completion date July 2013

Study information
Verified date March 2013
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Procedures scheduled for general anesthesia

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Agreement with invasively obtained PCO2 data within 5 mm Hg up to 24 months No
See also
  Status Clinical Trial Phase
Completed NCT02917668 - Evaluation of the Risk of Hyperoxia-induced Hypercapnia in Obese Cardiac Surgery Patients N/A
Terminated NCT02801162 - Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard N/A
Completed NCT02429154 - Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO) N/A
Not yet recruiting NCT02201875 - Intrinsic Periodic Pattern of Breathing N/A
Completed NCT02068274 - CO2 Monitoring Study N/A
Completed NCT01898858 - Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic N/A
Completed NCT00006318 - Role of Prostaglandins in the Regulation of Brain Blood Flow N/A
Completed NCT00001845 - Study of Brain Blood Flow During Induced Hypercapnia (Excess Blood Carbon Dioxide) N/A
Completed NCT05116397 - Influence of Graded Hypercapnia on Endurance Exercise Performance N/A
Completed NCT03221387 - Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients N/A
Completed NCT05470465 - Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation Phase 1
Recruiting NCT05505279 - Ventilatory Effects of THRIVE During EBUS Phase 3
Completed NCT04497090 - Adaptive Non-invasive Ventilation to Abolish Tidal Flow Limitation N/A
Completed NCT01882257 - Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury N/A
Terminated NCT00710541 - Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD) N/A
Completed NCT05189158 - Ventilatory Responses to Hypercapnic and Hypoxic Conditions in Hyperventilants N/A
Completed NCT04409470 - Venous Versus Arterial Blood Gas Sampling in Undifferentiated Emergency Patients
Completed NCT04512781 - Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs N/A
Recruiting NCT03741998 - Nasopharyngeal Airway Facilitate Transnasal Humidified Rapid Insufflation Ventilatory Exchange N/A
Recruiting NCT05761756 - Oxygen Toxicity: Mechanisms in Humans N/A