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Trial record 49 of 667 for:    CARBON DIOXIDE AND arterial

Transcutaneous Carbon-dioxide Monitoring in Electrophysiological Procedures in Deep Sedation (TRACES)

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ClinicalTrials.gov Identifier: NCT04038476
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Tillman Dahme, MD, University of Ulm

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.

Condition or disease Intervention/treatment Phase
Conscious Sedation During Procedure Ablation of Arrhythmias Diagnostic Test: Standard monitoring + transcutaneous CO2 monitoring Diagnostic Test: Standard monitoring Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective, Randomised Evaluation of Transcutaneous Carbon-dioxide Monitoring in Complex Electrophysiological Procedures in Deep Sedation
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

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Arm Intervention/treatment
Standard monitoring

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
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 + transcutaneous CO2 monitoring

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
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.




Primary Outcome Measures :
  1. Alteration of oxygen saturation [ Time Frame: during procedure ]
    Oxygen saturation change (spO2 < 90%)

  2. Alteration of pCO2 [ Time Frame: during procedure ]
    pCO2 change of > 30% of the initial value (measured in mmHg)

  3. Hypercapnia [ Time Frame: during procedure ]
    pCO2 > 70 mmHg in the venous blood gas analysis

  4. Respiratory acidosis [ Time Frame: during procedure ]
    pH < 7.25 (respiratory acidosis)


Secondary Outcome Measures :
  1. Alteration of systolic blood pressure [ Time Frame: during procedure ]
    systolic blood pressure < 80 mmHg

  2. Alteration of mean blood pressure [ Time Frame: during procedure ]
    mean arterial blood pressure < 65 mmHg

  3. Oxygen saturation change [ Time Frame: during procedure ]
    spO2 < 90%

  4. Change of pCO2 [ Time Frame: during procedure ]
    pCO2 change of > 30% of the initial value (measured in mmHg)

  5. Increase of pCO2 [ Time Frame: during procedure ]
    pCO2 > 70 mmHg in the venous blood gas analysis

  6. Alteraiont of blood pH [ Time Frame: during procedure ]
    pH < 7.25 (respiratory acidosis)

  7. Wake up behaviour [ Time Frame: up to 15 minutes postprocedural ]
    time until the patients is awakened (measured in minutes)

  8. Sedation associated postprocedural complications [ Time Frame: up to 30 minutes postprocedural ]
    postoperative nausea and vomiting (PONV)/Shivering



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient age ≥ 18 years
  2. Indication of electrophysiological intervention with the need for sedation during electrophysiological intervention
  3. Written consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038476


Contacts
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Contact: Karolina Weinmann, Dr. 004973150045188 karolina.weinmann@uniklinik-ulm.de
Contact: Tillman Dahme, PD Dr. 004973150045074 tillman.dahme@uniklinik-ulm.de

Locations
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Germany
Ulm University Medical Center, Internal Medicine II Recruiting
Ulm, Germany, 89081
Contact: Karolina Weinmann, MD    004973150045188    karolina.weinmann@uniklinik-ulm.de   
Contact: Tillman Dahme, MD    004973150045074    tillman.dahme@uniklinik-ulm.de   
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Tillman Dahme, PD Dr. University of Ulm

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Responsible Party: Tillman Dahme, MD, Head of electrophysiology department, University of Ulm
ClinicalTrials.gov Identifier: NCT04038476     History of Changes
Other Study ID Numbers: TCM1
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tillman Dahme, MD, University of Ulm:
electrophysiology
conscious sedation
transcutaneous CO2 measurement
sedation monitoring
ablation of arrhythmia
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs