Development of a Mass-spectometry Based Method for Detect... | NCT02105077

Studies
Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans

NCT02105077

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Completed

Last Update Posted

Mar 31, 2015Estimated

Enrollment

8Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

Anesthesia with inhalative application of xenon gas

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 31, 2014

First Submission Date that Met QC Criteria

Apr 2, 2014

First Posted Date

Apr 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Anästhesiologie, Prof. Dr. Peter Kienbaum, Heinrich-Heine University, DuesseldorfPrincipal Investigator

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

Collaborators

Name	Class
German Sport University, Cologne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.

Detailed Description

The noble gas xenon is used for general anesthesia in clinical routine. Recent reports indicate that xenon is also used for increasing performance in high-performance sports. The purpose of this study is to establish a method for detecting xenon exposure in humans.

In patients undergoing surgery with xenon anesthesia as part of routine hospital care, small blood samples (3ml) will be taken before anesthesia, during anaesthesia and at 1,2, 4, 8, 16, 24, 32, 40 and 48 hours after anesthesia. These blood samples will be analyzed for traces of xenon.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Xenon		Patients undergoing surgery with xenon-based general anesthesia	Drug: Anesthesia with inhalative application of xenon gas

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anesthesia with inhalative application of xenon gas	Drug		Xenon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of xenon in patient blood sample by mass spectrometry		Immediately before induction of anesthesia
Detection of xenon in patient blood sample by mass spectrometry		During xenon anesthesia
Detection of xenon in patient blood sample by mass spectrometry		4 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry		8 hours after extubation
Detection of xenon in patient blood sample by mass spectrometry		24 hours after xenon anesthesia

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 18 years and older
Xenon-based anesthesia as part of routine care

Exclusion Criteria:

Inability to give written informed consent
Known pregnancy
Hemoglobin concentration of less than 12g/dl

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing xenon-based general anesthesia as part of routine care at University Hospital Düsseldorf, Germany

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf		Düsseldorf		40225	Germany