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

NCT04586998 — Not applicable, Withdrawn, B. Braun Melsungen AG
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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

RegistryNCT04586998, acronym ProDect
StatusWithdrawn - Business decision
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
SponsorB. Braun Melsungen AG (Industry)
ConditionsElective Surgical Procedures, Anesthesia, Intravenous
InterventionsExhaled drug monitor "Edmon" (Device)
Datesstart 2021-04-01 (estimated), primary completion 2022-07-01 (estimated), completion 2022-07-01 (estimated), first posted 2020-10-14, last updated 2021-06-03

Related Papers Related Patents Related Grants Related Experts
All trials for Elective Surgical Procedures All trials for Anesthesia, Intravenous All trials of Exhaled drug monitor "Edmon"

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Exhaled drug monitor "Edmon"ExperimentalDevice: Exhaled drug monitor "Edmon"Comparison between propofol in exhaled breath and blood plasma
  • 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.

+Outcome measures

Primary outcomes

  • Propofol measurements [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.

Secondary outcomes

  • 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]: 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))
  • Evaluation of the correlation between propofol exhaled breath concentration and EEG index values [During elective surgical procedure lasting longer than 1 hour]: 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

+Eligibility

Sex: All, ages: 18 Years to any

* 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

+Investigators