Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring During PEG Placement
NCT ID: NCT04202029
Last Updated: 2023-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
173 participants
INTERVENTIONAL
2019-11-04
2021-08-24
Brief Summary
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Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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pulseoxymetry arm
pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
pulseoxymetry
Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
non-invasive blood preassure monitoring
Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
thoracic impedance monitoring
Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.
pulseoxymetry
Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
non-invasive blood preassure monitoring
Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
Interventions
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thoracic impedance monitoring
Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.
pulseoxymetry
Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
non-invasive blood preassure monitoring
Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
Eligibility Criteria
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Inclusion Criteria
* given consent
* planned PEG
Exclusion Criteria
* no given consent
* pregnant/laction
* contraindication against PEG
* contraindication against propofol-sedatation
18 Years
ALL
No
Sponsors
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Georg Dultz
OTHER
Responsible Party
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Georg Dultz
Clinical Professor
Locations
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Klinikum der J. W. Goethe-Universität
Frankfurt am Main, , Germany
Countries
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References
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Jafari A, Weismuller TJ, Tonguc T, Kalff JC, Manekeller S. [Complications after Percutaneous Endoscopic Gastrostomy Tube Placement - A Retrospective Analysis]. Zentralbl Chir. 2016 Aug;141(4):442-5. doi: 10.1055/s-0035-1557765. Epub 2015 Aug 10. German.
Riphaus A, Rabofski M, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: results from the first nationwide survey. Z Gastroenterol. 2010 Mar;48(3):392-7. doi: 10.1055/s-0028-1109765. Epub 2010 Feb 5.
Riphaus A, Geist F, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: re-evaluation from the first nationwide survey 3 years after the implementation of an evidence and consent based national guideline. Z Gastroenterol. 2013 Sep;51(9):1082-8. doi: 10.1055/s-0033-1335104. Epub 2013 Sep 10.
Lin OS. Sedation for routine gastrointestinal endoscopic procedures: a review on efficacy, safety, efficiency, cost and satisfaction. Intest Res. 2017 Oct;15(4):456-466. doi: 10.5217/ir.2017.15.4.456. Epub 2017 Oct 23.
Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol. 2010 Dec;27(12):1016-30. doi: 10.1097/EJA.0b013e32834136bf.
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.
Absolom M, Roberts R, Bahlmann UB, Hall JE, Armstrong T, Turley A. The use of impedance respirometry to confirm tracheal intubation in children. Anaesthesia. 2006 Dec;61(12):1145-8. doi: 10.1111/j.1365-2044.2006.04838.x.
Frasca D, Geraud L, Charriere JM, Debaene B, Mimoz O. Comparison of acoustic and impedance methods with mask capnometry to assess respiration rate in obese patients recovering from general anaesthesia. Anaesthesia. 2015 Jan;70(1):26-31. doi: 10.1111/anae.12799. Epub 2014 Jul 10.
Other Identifiers
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FRA-UNI-TIM-PEG-TRIAL-2019
Identifier Type: -
Identifier Source: org_study_id
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