Tissue Oxygen SaturationNIRSFEMNCT02038062
Tissue Oxygenation of the Tibial Anterior Muscle After Clamping of the Femoral Artery
A study testing Sevoflurane preconditioning in people with Tissue Oxygen Saturation, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tissue Oxygen Saturation
- What is being tested?
- Sevoflurane preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Influence of Sevoflurane Preconditioning on Tissue Oxygenation of the Tibial Anterior Muscle Measured by Near-infrared Spectroscopy After Clamping of the Femoral Artery for Vascular Surgery
Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.
Read the detailed description
Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in 40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation to 95 % of baseline.
- Conditions
- Tissue Oxygen Saturation
- Being tested
- Sevoflurane preconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane preconditioningProcedure or surgery
Preconditioning by transient application of sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Sevoflurane Preconditioning Receives: Procedure: Sevoflurane preconditioning |
| No Sevoflurane | No intervention | No Sevoflurane Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of tissue oxygen saturation below 95 % of baseline
Decrease of tissue oxygen saturation below 95 % of baseline
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tissue Oxygen SaturationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Fudickar, University Hospital Schleswig-Holstein
- Investigators
- Axel Fudickar, Dr., Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038062
- Sponsor's protocol ID
- Fudickar7
- Acronym
- NIRSFEM
- Status last verified
- Nov 2016
- First submitted
- 14 Jan 2014
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fudickar A, Kunath S, Voss D, Siggelkow M, Cavus E, Steinfath M, Bein B. Effect of ischemic and pharmacological preconditioning of lower limb muscle tissue on tissue oxygenation measured by near-infrared spectroscopy--a pilot study. BMC Anesthesiol. 2014 Jul 15;14:54. doi: 10.1186/1471-2253-14-54. eCollection 2014.
PubMed 25132803
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sevoflurane Preconditioning on Tissue Oxygenation of the Tibial Anterior Muscle Measured by Near-infrared Spectroscopy After Clamping of the Femoral Artery for Vascular Surgery
- ClinicalTrials.gov ID
- NCT02038062
- Acronym / sponsor ID
- NIRSFEM / Fudickar7
- Conditions
- Tissue Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Jan 2014 (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.
Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.
Detailed description
Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in 40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation to 95 % of baseline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Procedure: Sevoflurane preconditioningSevoflurane Preconditioning |
| No Sevoflurane | No intervention | –No Sevoflurane Preconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Sevoflurane preconditioningPreconditioning by transient application of sevoflurane | Procedure or surgery | Sevoflurane |
Primary outcome
Decrease of tissue oxygen saturation below 95 % of baseline
Time frame: 4 hours
Decrease of tissue oxygen saturation below 95 % of baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Derived from this study: PubMed 25132803Fudickar A, Kunath S, Voss D, Siggelkow M, Cavus E, Steinfath M, Bein B. Effect of ischemic and pharmacological preconditioning of lower limb muscle tissue on tissue oxygenation measured by near-infrared spectroscopy--a pilot study. BMC Anesthesiol. 2014 Jul 15;14:54. doi: 10.1186/1471-2253-14-54. eCollection 2014.
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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.
Axel Fudickar, Dr. principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane preconditioning in people with Tissue Oxygen Saturation, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 0 inclusion and 1 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: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of tissue oxygen saturation below 95 % of baseline (time frame: 4 hours). 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 NCT02038062, which also lists 1 linked publication.
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 29 Nov 2016.