AnesthesiaNCT02783443
Effect General and Regional Anesthesia on Glycocalyx
An observational study of Anesthesia and Glycocalyx, run by University Hospital Hradec Kralove.
Trial summary
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Glycocalyx, Perfused Boundary Region
- What is being tested?
- General anesthesia and Regional anesthesia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Who may be able to join
- Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Who cannot join
- None
About this study
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.
Read the detailed description
Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia.
The aim of the study: Comparison of two anaesthesia techniques with respect to GCX.
Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.
- Conditions
- Anesthesia, Glycocalyx, Perfused Boundary Region
- Being tested
- General anesthesia, Regional anesthesia
- Keywords
- Anesthesia, glycocalyx, perfused boundary region
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaOther
General anesthesia
Regional anesthesiaOther
Regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia. Receives: Other: General anesthesia | |
| Regional anesthesia | Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia. Receives: Other: Regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perfused Boundary Region (PBR)
PBR is an indirect measure of glycocalyx thickness
Measured: Change from baseline PBR at 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Cerny, University Hospital Hradec Kralove
- Investigators
- Vladimir Cerny, MD, Principal investigator, University Hospital Hradec Kralova, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783443
- Sponsor's protocol ID
- AZVCR 9307_2
- Status last verified
- Nov 2019
- First submitted
- 20 May 2016
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: On request if privacy guaranteed
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect General and Regional Anesthesia on Glycocalyx
- ClinicalTrials.gov ID
- NCT02783443
- Acronym / sponsor ID
- AZVCR 9307_2
- Conditions
- Anesthesia, Glycocalyx, Perfused Boundary Region
- Keywords
- Anesthesia, glycocalyx, perfused boundary region
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.
Detailed description
Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia.
The aim of the study: Comparison of two anaesthesia techniques with respect to GCX.
Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Other: General anesthesiaAdult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia. |
| Regional anesthesia | – | Other: Regional anesthesiaAdult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Key inclusion criteria (1 listed)
- Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| General anesthesiaGeneral anesthesia | Other | General anesthesia |
| Regional anesthesiaRegional anesthesia | Other | Regional anesthesia |
Primary outcome
Change in Perfused Boundary Region (PBR)
Time frame: Change from baseline PBR at 24 hours after surgery
PBR is an indirect measure of glycocalyx thickness
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. On request if privacy guaranteed
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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.
Vladimir Cerny, MD principal investigator
University Hospital Hradec Kralova, Czech Republic
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Glycocalyx, run by University Hospital Hradec Kralove.
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 1 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 27 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Perfused Boundary Region (PBR) (time frame: Change from baseline PBR at 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2019.