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

Georg Dultz

Status: Completed

Conditions: Percutaneous Endoscopic Gastrostomy (PEG)

Treatments: Device: non-invasive blood preassure monitoring; Device: pulseoxymetry; Device: thoracic impedance monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04202029

FRA-UNI-TIM-PEG-TRIAL-2019

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > /= 18 years
• given consent
• planned PEG

Exclusion criteria

• ASA >/= 4
• no given consent
• pregnant/laction
• contraindication against PEG
• contraindication against propofol-sedatation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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173 participants in 2 patient groups

pulseoxymetry arm

Other group

Description:

pulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring

Treatment:

Device: non-invasive blood preassure monitoring

Device: pulseoxymetry

thoracic impedance monitoring arm

Experimental group

Description:

thoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)

Treatment:

Device: thoracic impedance monitoring

Device: non-invasive blood preassure monitoring

Device: pulseoxymetry