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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Elective Surgical Procedures, Anesthesia, Intravenous

Intervention / Treatment
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* Device: Exhaled drug monitor Edmon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EDMON, Propofol detection, Exhaled breath, Drug monitoring