Transcutaneous Carbon-dioxide Monitoring in Electrophysiological Procedures in Deep Sedation

NCT04038476 | Active Not Recruiting

• 1 other identifier: TCM1
• Study Type: interventional
• Target: 726
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

electrophysiology; conscious sedation; transcutaneous CO2 measurement; sedation monitoring; ablation of arrhythmia

Outcome Measures

Primary Outcomes (4)

• Alteration of oxygen saturation

  Oxygen saturation change (spO2 \< 90%)

  during procedure

• Alteration of pCO2

  pCO2 change of \> 30% of the initial value (measured in mmHg)

  during procedure

• Hypercapnia

  pCO2 \> 70 mmHg in the venous blood gas analysis

  during procedure

• Respiratory acidosis

  pH \< 7.25 (respiratory acidosis)

  during procedure

Secondary Outcomes (8)

• Alteration of systolic blood pressure

  during procedure

• Alteration of mean blood pressure

  during procedure

• Oxygen saturation change

  during procedure

• Change of pCO2

  during procedure

• Increase of pCO2

  during procedure

Study Arms (2)

Standard monitoring

OTHER

When assigned to the group "Standard monitoring": In the area of the forehead of the patient, the adhesive electrode is attached according to manufacturer's instructions before the first dose of sedatives. The sedation monitoring is performed under standard conditions by continuous measurement of oxygen saturation, continuous circulatory monitoring (heart rate and regular non-invasive blood pressure measurements) and half-hourly venous blood gas analysis, on receipt in the left atrium an additional arterial blood gas analysis. The examiner (doctor or physicians involved in the study) are blinded to the transcutaneous CO2 measurement. An adjustment of the sedation management therefore takes place on the basis of the monitoring measures mentioned above. Transcutaneous CO2 monitoring is recorded in the background (Excel table of all registered values) and also monitored by the sedation assisting nurse and integrated into the standard sedation protocol.

Diagnostic Test: Standard monitoring

Standard monitoring + transcutaneous CO2 monitoring

OTHER

When assigned to the group "Standard monitoring + transcutaneous CO2 monitoring": In the area of the forehead of the patient, the adhesive electrode is attached according to manufacturer's instructions before the first dose of sedatives. The sedation monitoring is performed under standard conditions by continuous measurement of oxygen saturation, continuous circulatory monitoring (heart rate and regular non-invasive blood pressure measurements) and half-hourly venous blood gas analysis, on receipt in the left atrium an additional arterial blood gas analysis. In this group, the values of transcutaneous, continuous CO2 monitoring, including an alarm sound, are accessible to the treating physicians. Moreover, sedation management is adjusted on the basis of transcutaneous CO2 measurement. The above-mentioned measurements of the standard monitoring are carried out as described, in addition there is the the transcutaneous CO2 monitoring.

Diagnostic Test: Standard monitoring + transcutaneous CO2 monitoring

Interventions

Standard monitoring + transcutaneous CO2 monitoring DIAGNOSTIC_TEST

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.

Standard monitoring + transcutaneous CO2 monitoring

Standard monitoring DIAGNOSTIC_TEST

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.

Standard monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥ 18 years
• Indication of electrophysiological intervention with the need for sedation during electrophysiological intervention
• Written consent

You may not qualify if:

• Lack of written consent of the patient or lack of consent
• Contraindications / Incompatibilities to the attachment of the adhesive electrode (forehead)

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Ulm University Medical Center, Internal Medicine II

Ulm, 89081, Germany

Location

Related Publications (1)

• Teumer Y, Buss A, Diofano F, Aktolga D, Katov L, Bothner C, Dahme T, Ochsner W, Mayer B, Rottbauer W, Weinmann-Emhardt K. Prospective randomized evaluation of transcutaneous carbon dioxide monitoring during complex electrophysiological procedures under deep sedation: the TRACES trial. Clin Res Cardiol. 2024 Nov 7. doi: 10.1007/s00392-024-02570-8. Online ahead of print.

  PMID: 39508888 DERIVED

Study Officials

• Karolina Weinmann, PD Dr.

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 30, 2019
• Study Start: August 20, 2019
• Primary Completion: October 11, 2023
• Study Completion: November 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)