Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Exhaled Drug Monitor "Edmon"

NCT ID: NCT04586998

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-07-31

Brief Summary

Edmon is the first Communauté Européenne (CE) marked medical device able to continuously measure propofol in the exhaled breath of patients under sedation or anaesthesia with propofol. Current scientific publications indicate that it makes sense from a pharmacologic point of view to measure propofol in the exhaled air.

If the present study can show the Edmon to be able to detect small differences in propofol plasma concentration it will underline the clinical value of measuring propofol in the exhaled breath. This might be an opportunity for a significant improvement in patient monitoring.

Conditions

Elective Surgical Procedures; Anesthesia, Intravenous

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Exhaled drug monitor "Edmon"

Comparison between propofol in exhaled breath and blood plasma

Group Type: EXPERIMENTAL

Exhaled drug monitor "Edmon"

Intervention Type: DEVICE

Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points.

Interventions

Exhaled drug monitor "Edmon"

Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female patients undergoing elective surgical procedures
• Expected duration of the surgical procedure > 1h
• General anaesthesia (TIVA) with propofol and remifentanil under orotracheal intubation
• Medical need for an arterial line for an invasive haemodynamic monitoring during anaesthesia
• Written informed consent
• Age ≥ 18 years
• ASA I-III
• BMI < 35 kg/m²
• Women of child bearing potential: negative pregnancy test
• BIS monitoring feasible (e.g. no surgical procedures on the frontal brain)
• The patient is expected to be extubated in the OR after end of surgery

Exclusion Criteria

• Patients with contraindications for propofol, remifentanil or for the planned anaesthetic procedure
• Cardiac surgery
• Lung surgery
• Organ transplant procedures
• Pulmonary diffusion anomalies (e.g. pulmonary fibrosis), known from medical history
• Patients on renal replacement therapy
• Participation in another interventional trial
• Breastfeeding women
• Unilateral lung ventilation
• Emergency surgery
• Patient is not able to give his/her written informed consent
• Patients with a haemoglobin level below 10 g/dl

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Volk, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitaetsklinikum des Saarlandes

Other Identifiers

HC-G-H-1716

Identifier Type: -

Identifier Source: org_study_id