Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

Effect of Cervical Neck Collar and Head Blocks Strapped on the Backboard on Optic Nerve Sheath Diameter

Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

Study Overview

• Status: Unknown
• Conditions: Optic Nerve Sheath Diameter; Point of Care Ultrasound
• Intervention / Treatment: Device: cervical neck collar

Detailed Description

Two cervical immobilization devices will be used in this study named cervical neck collar and head blocks strapped on the backboard and optic nerve diameter will be measured using point of care ultrasound and compare the effect of each type of cervical immobilisation on optic nerve sheath diameter.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Recruiting
      • Mohamed Elbahnasawy
      • Contact: Mohamed G Elbahnasawy, MD; Phone Number: +20 01091291077; Email: drmogabehn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This prospective study will be done on 100 medical students, emergency medicine and traumatology residents and assistant lecturers ,Tanta university faculty of medicine, healthy volunteers during a period of 6 months.

Description

Inclusion Criteria:

• Adult healthy volunteers aged more than 18 years

Exclusion Criteria:

• Hx of stroke

  • Inability to consent,
  • Inability to lay flat on a bed or table for 15 min in duration,
  • History of glaucoma, globe injury, lens implant,
  • Recent refractive surgery (within the past 60 days).
  • Uncontrolled hypertension

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cervical neck collar	Device: cervical neck collar; devices used for cervical immobilization; Other Names: head blocks strapped on the backboard
head blocks strapped on the backboard	Device: cervical neck collar; devices used for cervical immobilization; Other Names: head blocks strapped on the backboard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of cervical neck collar and head blocks strapped on the backboard on Optic Nerve Sheath Diameter	effect of cervical neck collar and head blocks strapped on the backboard on optic nerve sheath diameter, measured by point of care ultrasound	6 month

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: cervical immobilization
• Other Study ID Numbers: 33935/7/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No