Clinical trial NCT04038476: Transcutaneous Carbon-dioxide Monitoring in Electrophysiological Procedures in Deep Sedation
Official title: Prospective, Randomised Evaluation of Transcutaneous Carbon-dioxide Monitoring in Complex Electrophysiological Procedures in Deep Sedation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Conscious Sedation During Procedure
Ablation of Arrhythmias
Keywords: electrophysiology
conscious sedation
transcutaneous CO2 measurement
sedation monitoring
ablation of arrhythmia
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Complex catheter ablations for treatment of supraventricular and ventricular tachycardias are performed under moderate to deep sedation.

These interventions include electrophysiological examinations such as cryo-pulmonary vein isolation as well as complex radiofrequency ablation using a 3D mapping system. In order to avoid complications and to achieve a successful ablation result, a quiet position of the patient should be ensured during the examination, which usually lasts several hours. Specific reasons for the need for sedation include:

1. Femoral access The access is, in most cases, the right femoral vein. By transseptal puncture of the atrial septum, the catheters are inserted into the left atrium, the most common target structure of the above mentioned procedures. In order to insert the catheter safely into the left atrium, the path from the right groin to the left atrium is secured by a guide rail, a so-called sheath. Due to this relatively rigid guide rail, unconsciously movements of the patient should be avoided during the examination.
2. 3D mapping system The 3D mapping system is used to create an individual, virtual, electro-anatomical map ("map of the structure and electrical activity of the heart") of the left atrium of the patient. The prerequisite for a millimeter accurate determination of the catheter position by means of magnetic fields is the patient's quiet position. Already deep breaths can endanger the catheter stability and thus the ablation result. By movements of the patient there is also the risk that the virtual 3D map no longer matches the real anatomy, this results in an increased risk of perforation in the left heart with the result of a pericardial effusion or tamponade.
3. Patient positioning The patient has to lie flat and quiet during the procedure. Keeping this position presents a challenge even for younger patients and short examination times and is therefore impractical for the patient for several hours for reasons of comfort.

The sedation usually consists of a combination of midazolam and propofol. At the beginning of the study, a midazolam bolus is administered and a low-dose propofol perfusor is started, which is increased during the course until an optimal sedation depth is reached. During ablation, opiates are also added for analgesia, depending on the procedure, consisting of fentanyl single doses or continuous administration of remifentanil with perfusor.

The sedation depth is primarily controlled clinically. The above-mentioned substances all have a respiratory depressive effect and can cause respiratory complications, in the sense of hypercapnia or hypoxia. Therefore, standard monitoring involves the continuous measurement of oxygen saturation by means of pulse oximetry (spO2) as well as the half-hourly analysis of a venous blood gas analysis to evaluate the pH and to monitor the carbon dioxide partial pressure (pCO2). For interventions in the left atrium there is also the possibility of an arterial blood gas analysis from the left atrium or, if present, arterial blood gas analysis from an arterial sheath. If abnormalities occur in the blood gas analysis, the depth of sedation is adjusted accordingly or the dosage of the various components of the sedation is adapted. In addition, there is a continuous heart rate measurement and regular non-invasive blood pressure measurements. The nurse, assisting the sedation, also provides a dedicated sedation protocol, with explanations of any change in sedation management during the procedure.

In the electrophysiology laboratory of the ulm university hospital is the option of continuous, transcutaneous CO2 monitoring using TCM 400 (Radiometer). For this purpose, an adhesive electrode (Severinghaus electrode) is attached to the forehead of the patient. Hereby, the measurement of the O2 and CO2 partial pressure in the underlying tissue can take place and with good blood flow, this value approaches the invasively gained gas values. This method ensures a continuous, non-invasive CO2 measurement. The collected parameters are stored by the TCM 400 device in an Excel spreadsheet and can be exported and analyzed after the procedure. The method was already used during complex catheter ablation as part of a small observational study, but does not yet count as standard monitoring.

So far, it is unclear to what extent a continuous, transcutaneous CO2 monitoring can prevent sedation-associated complications. The aim of this research project is the prospective, randomized analysis of the benefits of continuous, transcutaneous CO2 monitoring + standard monitoring in comparison to the previous standard monitoring. In particular, it should be investigated to what extent sedation-associated complications, such as oxygen saturation decreases, hypercapnia and respiratory acidosis can be prevented by continuous, transcutaneous CO2 monitoring.

Eligibility 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)

Primary outcomes:
measure: Alteration of oxygen saturation
timeFrame: during procedure
measure: Alteration of pCO2
timeFrame: during procedure
measure: Hypercapnia
timeFrame: during procedure
measure: Respiratory acidosis
timeFrame: during procedure
Secondary outcomes:
measure: Alteration of systolic blood pressure
timeFrame: during procedure
measure: Alteration of mean blood pressure
timeFrame: during procedure
measure: Oxygen saturation change
timeFrame: during procedure
measure: Change of pCO2
timeFrame: during procedure
measure: Increase of pCO2
timeFrame: during procedure
measure: Alteraiont of blood pH
timeFrame: during procedure
measure: Wake up behaviour
timeFrame: up to 15 minutes postprocedural
measure: Sedation associated postprocedural complications
timeFrame: up to 30 minutes postprocedural
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Ulm University Medical Center, Internal Medicine II
Study officials:
affiliation: University of Ulm
name: Karolina Weinmann, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: