NCT04507620

Brief Summary

Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 8, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 6, 2020

Last Update Submit

August 9, 2020

Conditions

Optic Nerve Sheath DiameterPoint of Care Ultrasound

Keywords

cervical immobilization

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

cervical neck collar

Device: cervical neck collar

head blocks strapped on the backboard

Device: cervical neck collar

Interventions

cervical neck collarDEVICE

devices used for cervical immobilization

Also known as: head blocks strapped on the backboard
cervical neck collarhead blocks strapped on the backboard

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Adult healthy volunteers aged more than 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Elbahnasawy

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant of emergency medicine and traumatology

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 11, 2020

Study Start

July 8, 2020

Primary Completion

November 1, 2020

Study Completion

November 30, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)