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

July 12, 2023 updated by: Georg Dultz

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt am Main, Germany, 60590
        • Klinikum der J. W. Goethe-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: pulseoxymetry arm
pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
Device: pulseoxymetry
Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
Device: non-invasive blood preassure monitoring
Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
Experimental: thoracic impedance monitoring arm
thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
Device: pulseoxymetry
Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
Device: non-invasive blood preassure monitoring
Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
Device: thoracic impedance monitoring
Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average duration period of PEG-placement: approx. 15 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of hypoxia-episodes in both arms
Time Frame: Average duration period of PEG-placement: approx. 15 minutes.
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.
Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 %
Time Frame: Average duration period of PEG-placement: approx. 15 minutes.
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.
Comparison of severe hypoxia-episodes in both arms
Time Frame: 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.
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.
Comparison of the time difference of occuring apnoe before hypoxia
Time Frame: Average duration period of PEG-placement: approx. 15 minutes.
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.
Specifity and sensetivity of thoracic impedance monitoring
Time Frame: Average duration period of PEG-placement: approx. 15 minutes.
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.
Additional cost of thoracic impedance monitoring (TIM)
Time Frame: Time frame is the entire study period with a maximum of 3 years.
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.
Risk stratification of baseline criteria for hypoxia
Time Frame: Time frame is the entire study period with a maximum of 3 years.
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.
Comparison of intervention procedures to prevent hypoxia
Time Frame: Average duration period of PEG-placement: approx. 15 minutes.
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.
Comparison of satisfaction of doctors in both arms
Time Frame: approx. 15 minutes
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
Comparison of satisfaction of nurses in both arms
Time Frame: approx. 15 minutes
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
Comparison of satisfaction of patients in both arms
Time Frame: approx. 15 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georg Dultz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2019

Primary Completion (Actual)

August 24, 2021

Study Completion (Actual)

August 24, 2021

Study Registration Dates

First Submitted

November 3, 2019

First Submitted That Met QC Criteria

December 15, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FRA-UNI-TIM-PEG-TRIAL-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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