NCT02783443

Brief Summary

Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

May 20, 2016

Results QC Date

March 25, 2019

Last Update Submit

November 8, 2019

Conditions

AnesthesiaGlycocalyxPerfused Boundary Region

Keywords

Anesthesia, glycocalyx, perfused boundary region

Outcome Measures

Primary Outcomes (1)

  • Change in Perfused Boundary Region (PBR)

    PBR is an indirect measure of glycocalyx thickness

    Change from baseline PBR at 24 hours after surgery

Study Arms (2)

General anesthesia

Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.

Other: General anesthesia

Regional anesthesia

Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.

Other: Regional anesthesia

Interventions

General anesthesiaOTHER

General anesthesia

General anesthesia
Regional anesthesiaOTHER

Regional anesthesia

Regional anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients ASA 2-3 undergoing elective total knee replacement surgery

You may qualify if:

  • Adult patients ASA 2-3 undergoing elective total knee replacement surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Anesthesia, GeneralAnesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Results Point of Contact

Title
Dr. David Astapenko
Organization
University Hospital Hradec Kralove
astapenko.d@seznam.cz
+420608177374

Study Officials

  • Vladimir Cerny, MD

    University Hospital Hradec Kralova, Czech Republic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Vladimir Cerny, MD, PhD, FCCM

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 26, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 27, 2019

Results First Posted

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

On request if privacy guaranteed