Elective Surgical ProceduresProDectNCT04586998
Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Exhaled Drug Monitor "Edmon"
A study testing Exhaled drug monitor "Edmon" in people with Elective Surgical Procedures and Anesthesia, Intravenous, run by B. Braun Melsungen AG.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgical Procedures, Anesthesia, Intravenous
- What is being tested?
- Exhaled drug monitor "Edmon"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
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.
- Being tested
- Exhaled drug monitor "Edmon"
- Keywords
- EDMON, Propofol detection, Exhaled breath, Drug monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Exhaled drug monitor "Edmon" | Experimental | Comparison between propofol in exhaled breath and blood plasma Receives: Device: Exhaled drug monitor "Edmon" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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))
Measured: 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
Measured: During elective surgical procedure lasting longer than 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study startApr 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Volk, Prof. Dr., Principal investigator, Universitaetsklinikum des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586998
- Sponsor's protocol ID
- HC-G-H-1716
- Acronym
- ProDect
- Status last verified
- May 2021
- First submitted
- 18 Sep 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04586998
- Acronym / sponsor ID
- ProDect / HC-G-H-1716
- Keywords
- EDMON, Propofol detection, Exhaled breath, Drug monitoring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaled drug monitor "Edmon" | Experimental | Device: Exhaled drug monitor "Edmon"Comparison between propofol in exhaled breath and blood plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
Key exclusion criteria (12 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaled drug monitor "Edmon"Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points. | Device | Exhaled drug monitor "Edmon" |
Primary outcome
Propofol measurements
Time frame: During elective surgical procedure lasting longer than 1 hour
To investigate the correlation between propofol concentrations in exhaled breath and blood plasma in patients undergoing elective surgical procedures under total intravenous anaesthesia.
2 secondary outcomes
Identification of confounders with an impact on propofol exhaled breath concentration, e.g.among ventilatory and circulatory parameters
Time frame: During elective surgical procedure lasting longer than 1 hour
Evaluation of the correlation between propofol exhaled breath concentration and EEG index values
Time frame: During elective surgical procedure lasting longer than 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
Related trials for Elective Surgical Procedures
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Not yet recruiting
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
Elective Primary THA or TKA
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Volk, Prof. Dr. principal investigator
Universitaetsklinikum des Saarlandes
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled drug monitor "Edmon" in people with Elective Surgical Procedures and Anesthesia, Intravenous, run by B. Braun Melsungen AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol measurements (time frame: During elective surgical procedure lasting longer than 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.