Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring During PEG Placement
- Conditions
- Percutaneous Endoscopic Gastrostomy (PEG)
- Interventions
- Device: thoracic impedance monitoringDevice: pulseoxymetryDevice: non-invasive blood preassure monitoring
- Registration Number
- NCT04202029
- Lead Sponsor
- Georg Dultz
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- > /= 18 years
- given consent
- planned PEG
- ASA >/= 4
- no given consent
- pregnant/laction
- contraindication against PEG
- contraindication against propofol-sedatation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description thoracic impedance monitoring arm non-invasive blood preassure monitoring thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement) pulseoxymetry arm non-invasive blood preassure monitoring pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring thoracic impedance monitoring arm pulseoxymetry thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement) thoracic impedance monitoring arm thoracic impedance monitoring thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement) pulseoxymetry arm pulseoxymetry pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
- Primary Outcome Measures
Name Time Method comparison of hypoxia in both arms Average duration period of PEG-placement: approx. 15 minutes. 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.
- Secondary Outcome Measures
Name Time Method Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 % Average duration period of PEG-placement: approx. 15 minutes. 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.
Additional cost of thoracic impedance monitoring (TIM) Time frame is the entire study period with a maximum of 3 years. 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.
Risk stratification of baseline criteria for hypoxia Time frame is the entire study period with a maximum of 3 years. Risk factors will be evaluated in an univariate and a multivariate analyse
Comparison of satisfaction of patients in both arms approx. 15 minutes 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.
Comparison of severe hypoxia-episodes in both arms 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. 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.
Comparison of the time difference of occuring apnoe before hypoxia Average duration period of PEG-placement: approx. 15 minutes. The time difference between the onset of apnoe befpre the onset of hypoxia will be meassured.
Specifity and sensetivity of thoracic impedance monitoring Average duration period of PEG-placement: approx. 15 minutes. 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.
Comparison of intervention procedures to prevent hypoxia Average duration period of PEG-placement: approx. 15 minutes. 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.
Comparison of satisfaction of doctors in both arms approx. 15 minutes 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.
Comparison of hypoxia-episodes in both arms Average duration period of PEG-placement: approx. 15 minutes. 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.
Comparison of satisfaction of nurses in both arms approx. 15 minutes 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.
Trial Locations
- Locations (1)
Klinikum der J. W. Goethe-Universität
🇩🇪Frankfurt am Main, Germany