Percutaneous Endoscopic Gastrostomy (PEG) Clinical Trial
— TIMPEGOfficial 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.
| Verified date | May 2020 |
| Source | Johann Wolfgang Goethe University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 173 |
| Est. completion date | August 24, 2021 |
| Est. primary completion date | August 24, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - > /= 18 years - given consent - planned PEG Exclusion Criteria: - ASA >/= 4 - no given consent - pregnant/laction - contraindication against PEG - contraindication against propofol-sedatation |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum der J. W. Goethe-Universität | Frankfurt am Main |
| Lead Sponsor | Collaborator |
|---|---|
| Georg Dultz |
Germany,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View 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. Erratum In: Z Gastroenterol. 2015 Aug;53(8):E1. German. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |