AnesthesiaPhase 4NCT02682758
Influence of Xenon Anaesthesia on Transpulmonary Pressure and Tidal Volume Distribution
A Phase 4 study testing Xenon in people with Anesthesia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Xenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Mar 2016
- Phase
- Phase 4
- 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
- Age over 18 years
- Xenon-based, general anaesthesia for elective surgery independent of this investigation
Who cannot join
- 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
Show all 9Show fewer
- Liver cirrhosis Child-Pugh B or C
- Therapeutic anticoagulation
- Cardiac pacemaker or internal automatic defibrillator
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Düsseldorf University Hospital
Düsseldorf, North Rhine-Westphalia, 40225
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Xenon
- Keywords
- xenon, transpulmonary pressure, electrical impedance tomography, tidal volume, esophageal pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called Xenon pro Anaesthesia
Wash-in of xenon for maintenance of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Patients of normal weight | Other | Patients undergoing routine xenon-based general anaesthesia for surgery with a body mass index of less than 30. Receives: Drug: Xenon |
| Obese patients | Other | Patients undergoing routine xenon-based general anaesthesia for surgery with a body mass index equal to or more than 30. Receives: Drug: Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transpulmonary pressure after Xenon wash-in
Measured: 5 minutes before and 5 minutes after xenon-wash in
Secondary outcomes (1)
Change in tidal volume Distribution as measured by Electrical impedance tomography
Measured: 5 minutes before induction of anaesthesia, 5 minutes before 5 minutes after xenon wash-in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kienbaum, MD, Principal investigator, Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682758
- Sponsor's protocol ID
- 5161R
- Status last verified
- Jan 2017
- First submitted
- 4 Feb 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Frerichs I, Dargaville PA, van Genderingen H, Morel DR, Rimensberger PC. Lung volume recruitment after surfactant administration modifies spatial distribution of ventilation. Am J Respir Crit Care Med. 2006 Oct 1;174(7):772-9. doi: 10.1164/rccm.200512-1942OC. Epub 2006 Jul 13.
PubMed 16840739Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.
PubMed 19652949Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016/j.bja.2018.02.064. Epub 2018 Apr 13.
PubMed 29793604
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Xenon Anaesthesia on Transpulmonary Pressure and Tidal Volume Distribution
- ClinicalTrials.gov ID
- NCT02682758
- Acronym / sponsor ID
- 5161R
- Conditions
- Anesthesia
- Keywords
- xenon, transpulmonary pressure, electrical impedance tomography, tidal volume, esophageal pressure measurement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Feb 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients of normal weight | Other | Drug: XenonPatients undergoing routine xenon-based general anaesthesia for surgery with a body mass index of less than 30. |
| Obese patients | Other | Drug: XenonPatients undergoing routine xenon-based general anaesthesia for surgery with a body mass index equal to or more than 30. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years
- Xenon-based, general anaesthesia for elective surgery independent of this investigation
Key exclusion criteria (9 listed)
- Inability to provide informed consent
- Known pregnancy
- American Society of Anesthesiologists status >III
- Restrictive or obstructive pulmonary disease
- History of esophageal or gastric operation
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 |
|---|---|---|
| XenonAlso: Xenon pro AnaesthesiaWash-in of xenon for maintenance of anaesthesia | Drug | Obese patients, Patients of normal weight |
Primary outcome
Change in transpulmonary pressure after Xenon wash-in
Time frame: 5 minutes before and 5 minutes after xenon-wash in
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Background: PubMed 16840739Frerichs I, Dargaville PA, van Genderingen H, Morel DR, Rimensberger PC. Lung volume recruitment after surfactant administration modifies spatial distribution of ventilation. Am J Respir Crit Care Med. 2006 Oct 1;174(7):772-9. doi: 10.1164/rccm.200512-1942OC. Epub 2006 Jul 13.
- Background: PubMed 19652949Zhao Z, Moller K, Steinmann D, Frerichs I, Guttmann J. Evaluation of an electrical impedance tomography-based Global Inhomogeneity Index for pulmonary ventilation distribution. Intensive Care Med. 2009 Nov;35(11):1900-6. doi: 10.1007/s00134-009-1589-y. Epub 2009 Aug 4.
- Derived from this study: PubMed 29793604Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016/j.bja.2018.02.064. Epub 2018 Apr 13.
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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.
Peter Kienbaum, MD principal investigator
Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xenon in people with Anesthesia, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in transpulmonary pressure after Xenon wash-in (time frame: 5 minutes before and 5 minutes after xenon-wash in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682758, which also lists 3 linked publications.
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 24 Jan 2017.