Venous bloodgassampling of a control group of healty patients who will be operated for elective surgery.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Complex Regionaal Pijn Syndroom Type 1 (CRPS I)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Control group for available results of study group CRPS I patients (1997)
Secondary outcome
na
Background summary
In patiƫnts with Complex Regionaal Pijn Syndroom type 1, who have been
operated, venous bloodgas sampling has been performed by prof Goris [1]. The
venous oxygen saturation seems very high (between 86-90%), in contrast with
literature.
We have sampled 25 venous bloodgasses of CRPS I patients. Control data for
venous oxygen saturation during operation were retrieved from the literature,
especially samples obtained during femoro-popliteal bypass grafting[2-4].
Unfortunately a healty control population is missing.
1. Goris RJA. Reflex Sympathetic Dystrophy: Model of a severe Regional
Inflammatoy Response Syndrome. World J Surg 1998;197-202.
2. Sonnenfeld T, Nowak J, Cronestrand R, Astrom H, Euler CV. LEg venous oxygen
saturation in the evaluation of intra-operative blood flow during arterial
reconstructive surgery. Scand J Clin Lab Invest 1979;39:577-584.
3. Keys A. The Oxygen saturation of the venous blood in normal human subjects.
J Appl Physiol 1938;13-21.
4. MacDonald MJ, Tarnopolsky MA, Green HJ, Hughson RL. Comparison of femoral
blood gases and muscle near-infrared spectroscopy at exercise onset in humans.
J Appl Physiol 1999;86:687-693.
Study objective
Venous bloodgassampling of a control group of healty patients who will be
operated for elective surgery.
Study design
AFter informed consent: 16 patients, undergoing elective surgery, venous
bloodgas sampling will be performed during operation under general anesthesia.
Two cc of blood will be taken, after that the groin will be pressed for one
minute and a bandage is left in place for 4-6 hrs.
Based on literature [2-4] for control population standard deviations are found
between 3 to 16, with an average venous bloodgas saturation of 62 to 71%. We
expect that the average venous saturation in the new population will be up to
80% (i.e. upper limit 95%-BI is maximum of 80%), as such the average will be
statistical significant from the CRPS patiƫnts (saturation >=91%). If we expect
that the standarddeviatie in SvO2 at least 20% from the new control population
with an avaerage of 70%, we need at least 16 patients with a standard error of
the mean of at least 5%.
Study burden and risks
One time puncture in groin for bloodgas sampling, risk of infection and
hematoma.
Geert Grooteplein 10
6525 GA, Nijmegen
Nederland
Geert Grooteplein 10
6525 GA, Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Healthy (ASA 1), above 18 years, no medication
Exclusion criteria
ASA 2 or higher, below 18 years of age, medication use
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 | NL20171.091.07 |