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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 173
- Locations
- 1
- Primary Endpoint
- comparison of hypoxia in both arms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> /= 18 years
- •given consent
- •planned PEG
Exclusion Criteria
- •ASA >/= 4
- •no given consent
- •pregnant/laction
- •contraindication against PEG
- •contraindication against propofol-sedatation
Arms & Interventions
pulseoxymetry arm
pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
Intervention: pulseoxymetry (Device)
pulseoxymetry arm
pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
Intervention: non-invasive blood preassure monitoring (Device)
thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
Intervention: thoracic impedance monitoring (Device)
thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
Intervention: pulseoxymetry (Device)
thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
Intervention: non-invasive blood preassure monitoring (Device)
Outcomes
Primary Outcomes
comparison of hypoxia in both arms
Time Frame: 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 Outcomes
- Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 %(Average duration period of PEG-placement: approx. 15 minutes.)
- Additional cost of thoracic impedance monitoring (TIM)(Time frame is the entire study period with a maximum of 3 years.)
- Risk stratification of baseline criteria for hypoxia(Time frame is the entire study period with a maximum of 3 years.)
- Comparison of satisfaction of patients in both arms(approx. 15 minutes)
- 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.)
- Comparison of the time difference of occuring apnoe before hypoxia(Average duration period of PEG-placement: approx. 15 minutes.)
- Specifity and sensetivity of thoracic impedance monitoring(Average duration period of PEG-placement: approx. 15 minutes.)
- Comparison of intervention procedures to prevent hypoxia(Average duration period of PEG-placement: approx. 15 minutes.)
- Comparison of satisfaction of doctors in both arms(approx. 15 minutes)
- Comparison of hypoxia-episodes in both arms(Average duration period of PEG-placement: approx. 15 minutes.)
- Comparison of satisfaction of nurses in both arms(approx. 15 minutes)
Investigators
Georg Dultz
Clinical Professor
Johann Wolfgang Goethe University Hospital