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HyperoxiaNCT02553668

Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression

A study testing Oxygen (FiO2 1,0) and Facemask in people with Hyperoxia, run by University Hospital of Cologne.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Hyperoxia
What is being tested?
Oxygen (FiO2 1,0) and Facemask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Oct 2015to Dec 2016
Phase
Interventional
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 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Stefan Braunecker, M.D. contact

stefan.braunecker@uk-koeln.de

Jochen Hinkelbein, M.D. contact

jochen.hinkelbein@uk-koeln.de

About this study

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.

Read the detailed description

Oxygen is necessary to sustain human life and is used for energy production by oxidation in the mitochondria. Application of oxygen not only increases saturation in the patient's blood, but also has various secondary effects. It is therefore used to treat diseases that impairs body's ability to take up and use oxygen. But even healthy people can suffer from hypoxia when they ascend to high altitude. Here, altitude sickness can lead to potentially fatal complications such as high altitude cerebral edema or high altitude pulmonary edema. Since hypoxia can have disastrous consequences, hyperoxia is often tolerated in many pre- and in-hospital situations.

Whereas the effects of hypoxia are well studied, especially publications in the last decade have led to a new perspective on oxygen application. Besides pathophysiological changes as the peripheral vasoconstriction or reduction of contractility, especially changes on cellular level seem to be of great importance. Here, oxidative stress and change of protein synthesis in various organ are focus of current studies.

The differential analysis of protein expression in tissues (proteomics) is an important approach for better understanding of the negative effects of hyperoxia. Especially for patients with long-term high oxygen demand the knowledge of cellular changes during hyperoxia can result in new therapeutic approaches and a reduction in the rate of complications.

In the present molecular biology study urine and blood samples of healthy volunteers will be collected at specified times after short-term exposure to oxygen. These samples will be analyzed after the study using the differential analysis of protein expression. The aim of this study is to investigate the effects of oxygen on the cell functions by analyzing and subsequent bioinformatic processing of differentially regulated proteins in the blood and urine.

After checking the inclusion and exclusion criteria biometric data of the test persons are collected.

Before short-term hyperoxia a sample collection of blood and urine will be performed. Here the participants are taken 5 ml of venous blood from the cephalic vein under sterile conditions. To obtain the urine sample spontaneous urine of participants is used. The samples are immediately centrifuged and flash frozen at -80°C. In order to exclude impairment of the lung prior to the short-term hyperoxia a pulmonary function test is carried out by using a hand spirometer.

To induce hyperoxia subjects inhale 100% oxygen for 3 hours through a face mask.

After carrying out the short term hyperoxia the follow up phase takes place. In this phase blood and urine samples from the subjects will be obtained directly after the hyperoxia (T0), on day 1 (T1), day 3 (T3), day 7 (T7), day 14 (T14), day 21 (T21) and day 28 (T28) after oxygen exposure. All samples will be centrifuged immediately after collection and flash frozen at -80 ° C. To exclude hyperoxia-induced lung impairments, a spirometry is performed during the follow up.

After the samples of all subjects were collected the analysis of the samples will be carried out using Proteomics.

Conditions
Hyperoxia
Being tested
Oxygen (FiO2 1,0), Facemask
Keywords
Proteomics, Oxygen, Pathways
Medical subject headings
Hyperoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxygen (FiO2 1,0)Drug

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

  • FacemaskDevice

Study groups in NCT02553668
Study groupRoleWhat they receive
HyperoxiaExperimentalParticipants receive 100% oxygen
Receives: Drug: Oxygen (FiO2 1,0); Device: Facemask

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of proteomics changes before and after short-term hyperoxia

    Measured: 4 weeks

Secondary outcomes (8)
  1. Spirometry Results: Forced vital capacity (FVC) [L]

    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.

    Measured: 2 days

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

    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.

    Measured: 2 days

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

    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.

    Measured: 2 days

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

    Spirometry will be used as a measure of safety to rule out adverse events of oxygen to the lung.

    Measured: 2 days

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

    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.

    Measured: 3 hours

  6. Vital parameter: Heart rate (HR) [1/min]

    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.

    Measured: 3 hours

  7. Vital parameter: Blood pressure (BP) [mmHg]

    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.

    Measured: 3 hours

  8. Vital parameter: Oxygen saturation (SpO2) [%]

    Vital parameters will be used as a measure of safety to rule out adverse events of oxygen to the vascular system.

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

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 N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02553668
Sponsor's protocol ID
15-109
Status last verified
Sep 2015
First submitted
9 Jul 2015
Last updated
17 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23934118
  • 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.

    PubMed 20049628

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen (FiO2 1,0) and Facemask in people with Hyperoxia, run by University Hospital of Cologne.

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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stefan Braunecker, M.D. (stefan.braunecker@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of proteomics changes before and after short-term hyperoxia (time frame: 4 weeks). 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 NCT02553668, which also lists 2 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 17 Sep 2015.

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