Percutaneous Endoscopic Gastrostomy (PEG)
Conditions
Keywords
ASA, American Socity of Anesthesiologists physical status classification system, Thoracic Impedance monitoring, TIM, ECG, echocardiography, sedation, propofol, monitoring, NAPS, nurse-administered propofol sedation, O2, oxygen, PEG, percutaneous endoscopic gastrostomy
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.
Interventions
DEVICEthoracic impedance monitoring
Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.
DEVICEpulseoxymetry
Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
DEVICEnon-invasive blood preassure monitoring
Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
Sponsors
Georg Dultz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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 ECG
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> /= 18 years * given consent * planned PEG
Exclusion criteria
* ASA \>/= 4 * no given consent * pregnant/laction * contraindication against PEG * contraindication against propofol-sedatation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 |
Countries
Germany
Outcome results
None listed