To investigate the effects of oxygen therapy within the first hour on the occurence of oxidative stress biomarkers at different levels of oxygenation (hypoxia, normoxia and hyperoxia).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Patienten met aandoeningen waarvoor zuurstof therapue noodzakelijk is voor of bij binnenkomst op de SEH
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence of oxidative stress biomarkers in patients who receive oxygen
therapy in the ED.
Secondary outcome
The association between blood oxygen saturation and the occurrence of the
different oxidative stress biomarkers.
Background summary
Much is known about the harmfull effects of hypoxia. For this reason, oxygen
therapy is given to acutely ill patients easily. However, the last few years
more and more is known about the detrimental effects of hyperoxia. Patients who
receive too much oxygen for a longer period of time (> 24 hours) have shown to
have increased comorbidities and even higher mortality rates. It is yet unknown
if these detrimental effects of hyperoxia are also apparant after a short
period of time (within 1 hour). Since the Emergency Departement is the
designated place to start oxygen therapy, it is important to investigate if we
should be cautious about the detrimental effects of a short period of hyperoxia
as well.
One way to investigate the harmfull effects of oxygen is to look at the
occurence of oxidative stress biomarkers in blood samples and urine. It is also
yet unknown if these biomarkers occur after a short period of time.
Study objective
To investigate the effects of oxygen therapy within the first hour on the
occurence of oxidative stress biomarkers at different levels of oxygenation
(hypoxia, normoxia and hyperoxia).
Study design
Single center prospective cohort study.
Study burden and risks
In all included patients, an extra blood sample (9 ml) will be obtained during
regular needle punction upon arrival. This will be performed trough the same
needle regular blood samples are obtained, so this gives no extra discomfort.
After 1 hour, a second blood sample of 9 ml will be obtained, which means 1
extra punction with a needle for the patients. Urine samples will also be
collected in patients who have to urinate within the first hour after arrival,
in whom a catheter will be placed or who already have a catheter. This meas
that the urine sample is optional: in patients without a catheter or who do not
have to urinate within the first hour, this sample will not be obtained.
Finally, patiens will receive a questionnaire 6 months after their ED visit by
email.
All this make the risks for included patient very small. The most important
risks are those who are part of standard drawing of blood (for example
pa/discomfort or hematoma).
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
- Non-trauma patients presenting to the ED who already receive oxygen therapy started by EMS or in whom oxygen therapy is started in the ED.
- Adult (i.e. age > 18 years)
- Able to provide (deferred) informed consent themselves or informed consent can be obtained via next of kin or legal guardian
Exclusion criteria
- Hypoxia (sat <94% or PaO2 < 10 kPa) despite oxygen suppletion
- Patients who receive oxygen therapy started by EMS > 30 minutes
- Patients with an acute coronary syndrome (ACS)
- Patients with Chronic Obstructive Pulmonary Syndrome (COPD) Gold III or IV
- Patient who were in cardiac arrest pre-hospital or who go into cardiac arrest in the first hour after arrival to the ED
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66915.099.18 |