Clinical trial NCT04202029: Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring During PEG Placement
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Endoscopic Gastrostomy (PEG)
Keywords: 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
percutaneous endoscopic gastrostomy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* \> /= 18 years
* given consent
* planned PEG

Exclusion Criteria:

* ASA \>/= 4
* no given consent
* pregnant/laction
* contraindication against PEG
* contraindication against propofol-sedatation

Primary outcomes:
measure: comparison of hypoxia in both arms
timeFrame: Average duration period of PEG-placement: approx. 15 minutes.
Secondary outcomes:
measure: Comparison of hypoxia-episodes in both arms
timeFrame: Average duration period of PEG-placement: approx. 15 minutes.
measure: Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 %
timeFrame: Average duration period of PEG-placement: approx. 15 minutes.
measure: Comparison of severe hypoxia-episodes in both arms
timeFrame: 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.
measure: Comparison of the time difference of occuring apnoe before hypoxia
timeFrame: Average duration period of PEG-placement: approx. 15 minutes.
measure: Specifity and sensetivity of thoracic impedance monitoring
timeFrame: Average duration period of PEG-placement: approx. 15 minutes.
measure: Additional cost of thoracic impedance monitoring (TIM)
timeFrame: Time frame is the entire study period with a maximum of 3 years.
measure: Risk stratification of baseline criteria for hypoxia
timeFrame: Time frame is the entire study period with a maximum of 3 years.
measure: Comparison of intervention procedures to prevent hypoxia
timeFrame: Average duration period of PEG-placement: approx. 15 minutes.
measure: Comparison of satisfaction of doctors in both arms
timeFrame: approx. 15 minutes
measure: Comparison of satisfaction of nurses in both arms
timeFrame: approx. 15 minutes
measure: Comparison of satisfaction of patients in both arms
timeFrame: approx. 15 minutes
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität
Study officials:
References:
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citation: Riphaus A, Wehrmann T, Hausmann J, Weber B, von Delius S, Jung M, Tonner P, Arnold J, Behrens A, Beilenhoff U, Bitter H, Domagk D, In der Smitten S, Kallinowski B, Meining A, Schaible A, Schilling D, Seifert H, Wappler F, Kopp I; German Society of General and Visceral Surgery; German Crohn's disease / ulcerative colitis Association e. V; German Society of Anaesthesiology and Intensive Care Medicine e. V. (DGAI); Gesellschaft Politics and Law in Health Care (GPRG). [S3-guidelines "sedation in gastrointestinal endoscopy" 2014 (AWMF register no. 021/014)]. Z Gastroenterol. 2015 Aug;53(8):802-42. doi: 10.1055/s-0035-1553458. Epub 2015 Aug 18. No abstract available. German.
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