Klinikum der J. W. Goethe-Universität
Frankfurt am Main, 60590, Germany
NCT Number: NCT04202029
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Frankfurt am Main, 60590, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.
Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
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.
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.
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.
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.
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.
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.
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: 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: 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.
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.
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.
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.
Georg Dultz
Other
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
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