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

NCT04586998 | Withdrawn

• 1 other identifier: HC-G-H-1716
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

EDMON; Propofol detection; Exhaled breath; Drug monitoring

Outcome Measures

Primary Outcomes (1)

• Propofol measurements

  To investigate the correlation between propofol concentrations in exhaled breath and blood plasma in patients undergoing elective surgical procedures under total intravenous anaesthesia.

  During elective surgical procedure lasting longer than 1 hour

Secondary Outcomes (2)

• Identification of confounders with an impact on propofol exhaled breath concentration, e.g.among ventilatory and circulatory parameters

  During elective surgical procedure lasting longer than 1 hour

• Evaluation of the correlation between propofol exhaled breath concentration and EEG index values

  During elective surgical procedure lasting longer than 1 hour

Study Arms (1)

Exhaled drug monitor "Edmon"

EXPERIMENTAL

Comparison between propofol in exhaled breath and blood plasma

Device: Exhaled drug monitor "Edmon"

Interventions

Exhaled drug monitor "Edmon" DEVICE

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

Exhaled drug monitor "Edmon"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Officials

• Thomas Volk, Prof. Dr.

  Universitaetsklinikum des Saarlandes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 14, 2020
• Study Start: April 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 3, 2021

Record last verified: 2021-05