Influence of Xenon Anaesthesia on Transpulmonary Pressure and Tidal Volume Distribution

January 23, 2017 updated by: Heinrich-Heine University, Duesseldorf
The influence of xenon anaesthesia on transpulmonary pressure and tidal volume distribution will be investigated in a prospective cohort study in 10 patients of normal weight and 10 obese patients undergoing routine xenon-based, general anaesthesia for surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To investigate the influence of xenon-anaesthesia on transpulmonary pressure and tidal volume Distribution, the investigators will enroll 20 patients - 10 with a Body mass index of less than 30 and 10 with a Body mass index of 30 or more - undergoing routine xenon-based anesthesia in the course of a prospective cohort study. Performance of anesthesia will be at the discretion of the attending anesthesiologist. Typically, xenon-based anesthesia is induced and initially maintained with propofol and an opioid and tracheal intubation is facilitated using a muscle relaxant. Initially, the patient is ventilated with 100 per cent oxygen in order to wash out nitrogen from the respirator and the lungs. When nitrogen wash-out is completed, 55-65 per cent xenon in oxygen is introduced.

5 minutes after anaesthesia induction, as well as 5 minutes after completion of Xenon wash-in, transpulmonary pressure will be measured from inspiratory plateau pressure and pleural pressure, which will be estimated from esophageal pressure. Esophageal pressure measurements will be facilitated via esophageal balloon catheters (Adult Esophageal Balloon Catheter Set 5 French, CooperSurgical, Trumbull, USA).

Tidal volume distribution will be assessed with the use of Electrical Impedance Tomography (EIT). Images will be acquired in the supine Position 5 minutes before anesthesia induction, 5 minutes after induction as well as 5 minutes completion of xenon wash-in. EIT measurements will be made for a period of one minute and functional EIT images of changes in tidal impedance will be generated. The Center of Ventilation Index and Global Inhomogeneity Index will be calculated for each time point.

Analysis Plan:

The primary analysis will include all recruited patients, irrespective of their Body mass index. Changes in transpulmonary pressure before and after Xenon wash-in will be assessed with the Wilcoxon signed-rank test for matched pairs. Center of Ventilation Index and Global Inhomogeneity Index, which will be assessed at three time points, will be compared with the use of repeated measures ANOVA with the post-hoc Sidak test.

Secondary subgroup analyses will consist of separate analyses for patients with a BMI over or equal to and a BMI of less than 30. A type I error will be accepted with a maximum probability of 0.05.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Düsseldorf, NRW, Germany, 40225
        • Department of Anesthesiology, Düsseldorf University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18 years
  • Xenon-based, general anaesthesia for elective surgery independent of this investigation

Exclusion Criteria:

  • Inability to provide informed consent
  • Known pregnancy
  • American Society of Anesthesiologists status >III
  • Restrictive or obstructive pulmonary disease
  • History of esophageal or gastric operation
  • Esophageal varices
  • Liver cirrhosis Child-Pugh B or C
  • Therapeutic anticoagulation
  • Cardiac pacemaker or internal automatic defibrillator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients of normal weight
Patients undergoing routine xenon-based general anaesthesia for surgery with a body mass index of less than 30.
Drug: Xenon
Wash-in of xenon for maintenance of anaesthesia
Other Names:
  • Xenon pro Anaesthesia
OTHER: Obese patients
Patients undergoing routine xenon-based general anaesthesia for surgery with a body mass index equal to or more than 30.
Drug: Xenon
Wash-in of xenon for maintenance of anaesthesia
Other Names:
  • Xenon pro Anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in transpulmonary pressure after Xenon wash-in
Time Frame: 5 minutes before and 5 minutes after xenon-wash in
5 minutes before and 5 minutes after xenon-wash in

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in tidal volume Distribution as measured by Electrical impedance tomography
Time Frame: 5 minutes before induction of anaesthesia, 5 minutes before 5 minutes after xenon wash-in
5 minutes before induction of anaesthesia, 5 minutes before 5 minutes after xenon wash-in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Peter Kienbaum, MD, Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (ESTIMATE)

February 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5161R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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