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.
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
Jochen Hinkelbein, M.D. contact
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 group | Role | What they receive |
|---|---|---|
| Hyperoxia | Experimental | Participants 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.
Comparison of proteomics changes before and after short-term hyperoxia
Measured: 4 weeks
Secondary outcomes (8)
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
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
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
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
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
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
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
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.
- First posted17 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Stefan Braunecker, University Hospital of Cologne
- Investigators
- Stefan Braunecker, M.D., Principal investigator, Universityhospital of Cologne
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 23934118Hinkelbein 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics for Identification of Hyperoxia-induced Changes in Protein Expression
- ClinicalTrials.gov ID
- NCT02553668
- Acronym / sponsor ID
- 15-109
- Conditions
- Hyperoxia
- Keywords
- Proteomics, Oxygen, Pathways
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 17 Sep 2015 (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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperoxia | Experimental | Drug: Oxygen (FiO2 1,0), Device: FacemaskParticipants receive 100% oxygen |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) 1
- >18 years
- < 50 years
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) > 1
- pregnant
- <18 years
- > 50 years
- frequent or recent drug intake
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 |
|---|---|---|
| Oxygen (FiO2 1,0)Participants will inhale Oxygen (FiO2 1,0) via Facemask for 3 hours. | Drug | Hyperoxia |
| Facemask | Device | Hyperoxia |
Primary outcome
Comparison of proteomics changes before and after short-term hyperoxia
Time frame: 4 weeks
8 secondary outcomes
Spirometry Results: Forced vital capacity (FVC) [L]
Time frame: 2 days
Spirometry Results: Forced expiratory volume at one second (FEV1) [L]
Time frame: 2 days
Spirometry Results: Forced expiratory flow (FEF25-75) [L/s]
Time frame: 2 days
Spirometry Results: Peak expiratory flow (PEF) [L/s]
Time frame: 2 days
Vital parameter: Respiratory rate (RR) [1/min]
Time frame: 3 hours
Vital parameter: Heart rate (HR) [1/min]
Time frame: 3 hours
Vital parameter: Blood pressure (BP) [mmHg]
Time frame: 3 hours
Vital parameter: Oxygen saturation (SpO2) [%]
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Background: PubMed 23934118Spelten 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.
- Background: PubMed 20049628Hinkelbein 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.
Related trials for Hyperoxia
Not yet recruiting
Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia
Recruiting
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia
Ventilatory Depression, Postoperative Respiratory Failure
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.
Stefan Braunecker, M.D. contact
Jochen Hinkelbein, M.D. contact
Stefan Braunecker, M.D. principal investigator
Universityhospital of Cologne
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.