NCT02553668

Brief Summary

Aim of the present study is to investigate the influence of hyperoxia on the protein expression using the differential analysis of protein expression in tissues (proteomics). In the study, blood and urine samples will be collected from participants who undergo a short term hyperoxia using 100% oxgen for 3 hours. Here, gel electrophoresis, protein separation and mass spectroscopy allow to identify affected proteins. Based on these results, different induction factors of proteins will be determined and then assessed using a bioinformatic network analysis regarding the cellular influence.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

July 9, 2015

Last Update Submit

September 16, 2015

Conditions

Keywords

ProteomicsOxygenPathways

Outcome Measures

Primary Outcomes (1)

  • Comparison of proteomics changes before and after short-term hyperoxia

    4 weeks

Secondary Outcomes (8)

  • Spirometry Results: Forced vital capacity (FVC) [L]

    2 days

  • Spirometry Results: Forced expiratory volume at one second (FEV1) [L]

    2 days

  • Spirometry Results: Forced expiratory flow (FEF25-75) [L/s]

    2 days

  • Spirometry Results: Peak expiratory flow (PEF) [L/s]

    2 days

  • Vital parameter: Respiratory rate (RR) [1/min]

    3 hours

  • +3 more secondary outcomes

Study Arms (1)

Hyperoxia

EXPERIMENTAL

Participants receive 100% oxygen

Drug: Oxygen (FiO2 1,0)Device: Facemask

Interventions

Participants will inhale Oxygen (FiO2 1,0) via Facemask for 3 hours.

Hyperoxia
FacemaskDEVICE
Hyperoxia

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) 1
  • \>18 years
  • \< 50 years

You may not qualify if:

  • American Society of Anesthesiologists (ASA) \> 1
  • pregnant
  • \<18 years
  • \> 50 years
  • frequent or recent drug intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Spelten O, Wetsch WA, Wrettos G, Kalenka A, Hinkelbein J. Response of rat lung tissue to short-term hyperoxia: a proteomic approach. Mol Cell Biochem. 2013 Nov;383(1-2):231-42. doi: 10.1007/s11010-013-1771-y. Epub 2013 Aug 11.

    PMID: 23934118BACKGROUND
  • Hinkelbein J, Feldmann RE Jr, Kalenka A. Time-dependent alterations of cerebral proteins following short-term normobaric hyperoxia. Mol Cell Biochem. 2010 Jun;339(1-2):9-21. doi: 10.1007/s11010-009-0365-1. Epub 2010 Jan 5.

    PMID: 20049628BACKGROUND

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Stefan Braunecker, M.D.

    Universityhospital of Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Braunecker, M.D.

CONTACT

Jochen Hinkelbein, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

July 9, 2015

First Posted

September 17, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

September 17, 2015

Record last verified: 2015-09