Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring During PEG Placement

NCT04202029 | Completed

• 1 other identifier: FRA-UNI-TIM-PEG-TRIAL-2019
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Comparison of hypoxia-episodes in both arms

  Average duration period of PEG-placement: approx. 15 minutes.

• Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 %

  Average duration period of PEG-placement: 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.

Study Arms (2)

pulseoxymetry arm

OTHER

pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring

Device: pulseoxymetry; Device: non-invasive blood preassure monitoring

thoracic impedance monitoring arm

EXPERIMENTAL

thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)

Device: thoracic impedance monitoring; Device: pulseoxymetry; Device: non-invasive blood preassure monitoring

Interventions

thoracic impedance monitoring DEVICE

Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.

thoracic impedance monitoring arm

pulseoxymetry DEVICE

Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood

pulseoxymetry arm; thoracic impedance monitoring arm

non-invasive blood preassure monitoring DEVICE

Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.

pulseoxymetry arm; thoracic impedance monitoring arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Georg Dultz: lead

Study Sites (1)

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, 60590, Germany

Location

Related Publications (8)

• 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.

  PMID: 26258619 BACKGROUND

• 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.

  PMID: 20140841 BACKGROUND

• 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.

  PMID: 24022202 BACKGROUND

• 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.

  PMID: 29142513 BACKGROUND

• 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.

  PMID: 21068575 BACKGROUND

• 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.

  PMID: 26284330 BACKGROUND

• 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.

  PMID: 17090233 BACKGROUND

• 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.

  PMID: 25040754 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: December 17, 2019
• Study Start: November 4, 2019
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: July 13, 2023

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)