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

Prospective Multicenter Open-Label Single Group Study on the Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Propofol Monitor Edmon in Patients Undergoing Elective Surgery Under Total Intravenous Anaesthesia

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.

Study Overview

• Status: Withdrawn
• Conditions: Anesthesia, Intravenous; Elective Surgical Procedures
• Intervention / Treatment: Device: Exhaled drug monitor "Edmon"

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exhaled drug monitor "Edmon"; Comparison between propofol in exhaled breath and blood plasma	Device: Exhaled drug monitor "Edmon"; Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of confounders with an impact on propofol exhaled breath concentration, e.g.among ventilatory and circulatory parameters	To identify confounders among ventilatory and circulatory parameters by correlating the course of propofol values with courses of single parameters from vital sign monitor or anaesthetic machine (e.g. systolic blood pressure or positive end-expiratory pressure (PEEP))	During elective surgical procedure lasting longer than 1 hour
Evaluation of the correlation between propofol exhaled breath concentration and EEG index values	For that correlation EEG index values (Bispectral index (BIS) and suppression ratio) will be corrected by calculated remifentanil plasma concentration and then correlated to propofol exhaled breath concentrations	During elective surgical procedure lasting longer than 1 hour

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Thomas Volk, Prof. Dr., Universitaetsklinikum des Saarlandes

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: EDMON; Propofol detection; Exhaled breath; Drug monitoring
• Other Study ID Numbers: HC-G-H-1716

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No