At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating thoracic impedance monitoring, pulseoxymetry, and 1 other intervention for Percutaneous Endoscopic Gastrostomy (PEG). Completed, enrolled 173 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.