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

Anesthesia, Intravenous Clinical Trial

— ProDect  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04586998
• Other study ID #: HC-G-H-1716
• Status: Withdrawn
• Phase: N/A
• Start date: April 2021
• Est. completion date: July 2022

Study information

• Verified date: May 2021
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Anesthesia, Intravenous
• Elective Surgical Procedures

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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