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Transcutaneous Carbon-dioxide Monitoring in Electrophysiological Procedures in Deep Sedation

NCT04038476 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 726

Last updated 2024-02-08

No results posted yet for this study

Summary

Complex procedures for treatment of cardiac arrhythmias are usually performed under deep sedation, since a quiet position of the patient is usually required over several hours and a significant risk of injury is caused by unconsciously movements of the patient. The sedative medication inhibits respiration. This can result in an increase of CO2-levels or a reduction oxygen-levels in the blood. Therefore, oxygen saturation (finger clip) is monitored continuously and the CO2-levels in the blood are evaluated every half hour. The study aims to evaluate, whether additional continuous CO2 measurement (transcutaneous CO2 monitoring) has a safety benefit for patients in sedation. Patients are randomly divided into two groups. The first group receives the previous standard monitoring and the second group additionally receives the transcutaneous CO2 measurement. After completion of the procedure, all study-relevant parameters are collected. Finally, the investigators examine whether oxygen saturation decreases or CO2-level increases could be prevented by a continuous, transcutaneous CO2 measurement.

Conditions

  • Conscious Sedation During Procedure
  • Ablation of Arrhythmias

Interventions

DIAGNOSTIC_TEST

Standard monitoring + transcutaneous CO2 monitoring

The transcutaneous CO2 Monitoring measures the CO2 partial pressure of the skin and in condition of good circulation these values approximate the arterial/venous CO2 partial pressure. The sensor is placed on the forehead. The physician adapts the sedation Management according to the transcutaneous CO2 monitoring.

DIAGNOSTIC_TEST

Standard monitoring

The transcutaneous CO2-sensor is also positioned on the patients' forehead, but the transcutaneous CO2-monitoring is not available for the physician to adapt the sedative management.

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Karolina Weinmann, PD Dr. · University of Ulm

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2023-10-11
Completion
2024-11-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038476 on ClinicalTrials.gov