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

Sponsor

Georg Dultz (Other)

Overall Status

Unknown status

CT.gov ID

NCT04202029

Collaborator

(none)

172

Enrollment

Location

Arms

30.9

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Endoscopic Gastrostomy (PEG)	Device: thoracic impedance monitoring Device: pulseoxymetry Device: non-invasive blood preassure monitoring	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 ECGThe 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

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official 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.

Actual Study Start Date :

Nov 4, 2019

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

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

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: thoracic impedance monitoring

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

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.

Outcome Measures

Primary Outcome Measures

comparison of hypoxia in both arms [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 Outcome Measures

Comparison of hypoxia-episodes in both arms [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.
Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 % [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.
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.]
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.
Comparison of the time difference of occuring apnoe before hypoxia [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.
Specifity and sensetivity of thoracic impedance monitoring [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.
Additional cost of thoracic impedance monitoring (TIM) [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.
Risk stratification of baseline criteria for hypoxia [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
Comparison of intervention procedures to prevent hypoxia [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.
Comparison of satisfaction of doctors in both arms [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.
Comparison of satisfaction of nurses in both arms [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.
Comparison of satisfaction of patients in both arms [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.