Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring During PEG Placement

Study Overview
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Brief Summary
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The present study is a randomized, prospective, single-blinded study. A total of 172 patients presenting for percoutaneous endoscopic gastrostomy (PEG) under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- standard monitoring (pulseoxymetry and non-invasive blood preassure monitoring) or group 2- standard monitoring and thoracic impedance measurement during Propofol-based sedation for PEG. Episodes of Hypoxia are documented and compared in both groups. Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.

Official Title
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Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring by Non- Anesthesiologist During Percutaneous Endoscopic Gastrostomy (PEG), a Prospective, Randomized-controlled Clinical Study.

Conditions
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Percutaneous Endoscopic Gastrostomy (PEG)

Intervention / Treatment
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* Device: thoracic impedance monitoring
* Device: pulseoxymetry
* Device: non-invasive blood preassure monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > /= 18 years given consent planned PEG Exclusion Criteria: ASA >/= 4 no given consent pregnant/laction contraindication against PEG contraindication against propofol-sedatation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants will be randomely assigend by a computer based algorithm to either the standard monitoring group as defined by the German S3 guidline Sedierung in der gastrointestinalen Endoskopie containing pulsoxymetry and non-invasive blood preassure monitoring versus the standard and additionally the thoracic impedance monitoring using an extra ECG
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pulseoxymetry arm<br>pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring | Device: pulseoxymetry<br>* Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood<br>Device: non-invasive blood preassure monitoring<br>* Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.<br>|
| Experimental: thoracic impedance monitoring arm<br>thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement) | Device: thoracic impedance monitoring<br>* Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.<br>Device: pulseoxymetry<br>* Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood<br>Device: non-invasive blood preassure monitoring<br>* Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of hypoxia in both arms | Hypoxia is defined as oxygen saturation dropping below 90 % for more than 15 seconds. The primary end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient. | Average duration period of PEG-placement: approx. 15 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of hypoxia-episodes in both arms | Number of hypoxia-episodes during each intervention. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient. | Average duration period of PEG-placement: approx. 15 minutes. | 
| Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 % | Severe hypoxia is defined as O2 saturation below 85%. This end point is assessed from the beginning of propofol sedatio n until the PEG-procedure is terminated defined by awaking of the patient. | Average duration period of PEG-placement: approx. 15 minutes. | 
| Comparison of severe hypoxia-episodes in both arms | The number of hypoxia-episodes during each intervention will be assesed. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient. | Average duration period of PEG-placement: approx. 15 minutes. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient. | 
| Comparison of the time difference of occuring apnoe before hypoxia | The time difference between the onset of apnoe befpre the onset of hypoxia will be meassured. | Average duration period of PEG-placement: approx. 15 minutes. | 
| Specifity and sensetivity of thoracic impedance monitoring | The specifity and sensitivity will be calculated using the frequency of falls alarms and missed alarms in relation to hypoxia. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient. | Average duration period of PEG-placement: approx. 15 minutes. | 
| Additional cost of thoracic impedance monitoring (TIM) | The costs that are needed to implement TIM during every procedure will be calculated and will be stated in the results. All PEG-placements in the TIM group will be used. By using a 3-lead-ECG, 3 electrodes will be needed per patient. For alle patients, one ECG-cable will be needed. Therefore, the costs will be calculated per patient. | Time frame is the entire study period with a maximum of 3 years. | 
| Risk stratification of baseline criteria for hypoxia | Risk factors will be evaluated in an univariate and a multivariate analyse | Time frame is the entire study period with a maximum of 3 years. | 
| Comparison of intervention procedures to prevent hypoxia | The necessity to prevent a hypoxic event because of an alarm by the monitoring by elevating the oxygen delivery, using jaw thrust manoeuvre or mask ventilation will be compared in both arms. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by the awaking of the patient. | Average duration period of PEG-placement: approx. 15 minutes. | 
| Comparison of satisfaction of doctors in both arms | The involved doctors will be asked to give there opinion using visual analog scale (VAS). Scale reaches from 1 (dissatisfied) to 10 (satisfied). The end point will be meassured after the procedure. The investigation time is defined as one PEG-placement. | approx. 15 minutes | 
| Comparison of satisfaction of nurses in both arms | The involved nurses will be asked to give there opinion using visual analog scale (VAS). Scale reaches from 1 (dissatisfied) to 10 (satisfied). The end point will be meassured after the procedure. The investigation time is defined as one PEG-placement. | approx. 15 minutes | 
| Comparison of satisfaction of patients in both arms | The involved patients will be asked to give there opinion using visual analog scale (VAS). Scale reaches from 1 (dissatisfied) to 10 (satisfied). The end point will be meassured after the procedure. The investigation time is defined as one PEG-placement. | approx. 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous endoscopic gastrostomy, ASA, American Socity of Anesthesiologists physical status classification system, Thoracic Impedance monitoring, TIM, ECG, echocardiography, sedation, propofol, monitoring, NAPS, nurse-administered propofol sedation, O2, oxygen, PEG