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Completed

NCT Number: NCT04202029

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

thoracic impedance monitoring

Device

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

pulseoxymetry

Device

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

non-invasive blood preassure monitoring

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Georg Dultz

Other

Registry information

Official study 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.

Acronym: TIMPEG

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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