NCT04202029

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Georg Dultz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Percutaneous Endoscopic Gastrostomy (PEG)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-04
• Primary completion: 2021-08-24
• Completion: 2021-08-24
• First posted: 2019-12-17
• Last updated: 2023-07-13

Locations

1 site across 1 country: Germany