Effect of Cervical Immobilization on Optic Nerve Sheath D... | NCT04507620

Studies
Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

NCT04507620

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Aug 11, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Optic Nerve Sheath Diameter
Point of Care Ultrasound

Interventions

cervical neck collar

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 8, 2020Actual

Primary Completion Date

Nov 1, 2020Estimated

Completion Date

Nov 30, 2020Estimated

First Submitted Date

Aug 6, 2020

First Submission Date that Met QC Criteria

Aug 9, 2020

First Posted Date

Aug 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2020

Last Update Posted Date

Aug 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Elbahnasawy, MD, consultant of emergency medicine and traumatology, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of Cervical Immobilization on Optic Nerve Sheath Diameter

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cervical neck collar			Device: cervical neck collar
head blocks strapped on the backboard			Device: cervical neck collar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cervical neck collar	Device	devices used for cervical immobilization	cervical neck collar head blocks strapped on the backboard

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohamed Elbahnasawy	Recruiting	Tanta	Gharbia Governorate	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided