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

Comparison of hypoxia-episodes in both arms

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.

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

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.

Comparison of severe hypoxia-episodes in both arms

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. 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

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.

Specifity and sensetivity of thoracic impedance monitoring

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

Additional cost of thoracic impedance monitoring (TIM)

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 stratification of baseline criteria for hypoxia

Risk factors will be evaluated in an univariate and a multivariate analyse

Time frame: Time frame is the entire study period with a maximum of 3 years.

Comparison of intervention procedures to prevent hypoxia

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

Comparison of satisfaction of doctors in both arms

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

Comparison of satisfaction of nurses in both arms

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

Comparison of satisfaction of patients in both arms

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.

Time frame: approx. 15 minutes