NCT04758091

Brief Summary

The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 8, 2021

Last Update Submit

February 12, 2021

Conditions

Intracranial Pressure Increase

Keywords

Optic Nerve Sheath DiameterTourniquetCerebral Oxygenation

Outcome Measures

Primary Outcomes (2)

  • optic nerve diameter

    measuring the change in optic nerve diameter

    during the surgery

  • regional cerebral oxgenation

    measurement rSo2 by Near Infrared spectroscopy

    during the surgery

Eligibility Criteria

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

lower extremity surgery with tourniquet

You may qualify if:

  • ASA I-II risk group over the age of 18
  • Operation planned under general anesthesia
  • Lower extremity surgery with a tourniquet
  • Agreeing to volunteer for research with an informed consent form

You may not qualify if:

  • Emergency surgical procedures
  • neurological disease, carotid disease
  • Previous intracranial or ocular surgery
  • Neurological symptoms
  • cerebral edema, high IntraCranial Pressure
  • Presence of glaucoma
  • Body mass index (BMI)\> 35
  • Uncontrolled hypertension
  • Diabetic retinopathy
  • anemia
  • coronary artery disease
  • peripheral artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 17, 2021

Study Start

April 15, 2019

Primary Completion

December 15, 2019

Study Completion

June 1, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)