跳至主要内容
临床试验/NCT04038476
NCT04038476进行中(未招募)不适用

Prospective, Randomised Evaluation of Transcutaneous Carbon-dioxide Monitoring in Complex Electrophysiological Procedures in Deep Sedation

University of Ulm1 个研究点 分布在 1 个国家目标入组 726 人开始时间: 2019年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
726
试验地点
1
主要终点
Alteration of pCO2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Standard monitoring (Diagnostic Test)

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.

干预措施: Standard monitoring + transcutaneous CO2 monitoring (Diagnostic Test)

结局指标

主要结局

Alteration of pCO2

时间窗: during procedure

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

Hypercapnia

时间窗: during procedure

pCO2 \> 70 mmHg in the venous blood gas analysis

Alteration of oxygen saturation

时间窗: during procedure

Oxygen saturation change (spO2 \< 90%)

Respiratory acidosis

时间窗: during procedure

pH \< 7.25 (respiratory acidosis)

次要结局

  • Alteration of mean blood pressure(during procedure)
  • Oxygen saturation change(during procedure)
  • Change of pCO2(during procedure)
  • Alteration of systolic blood pressure(during procedure)
  • Increase of pCO2(during procedure)
  • Alteraiont of blood pH(during procedure)
  • Wake up behaviour(up to 15 minutes postprocedural)
  • Sedation associated postprocedural complications(up to 30 minutes postprocedural)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Karolina Weinmann

Cardiologist

University of Ulm

研究点 (1)

Loading locations...

相似试验