Trial Outcomes & Findings for Effect of Cervical Collar on the Optic Nerve Sheath Diameter in Minor Head Trauma (NCT NCT03742427)

NCT ID: NCT03742427

Last Updated: 2021-06-18

Results Overview

We hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

20 minutes

Results posted on

2021-06-18

Participant Flow

Participant milestones

Participant milestones
Measure
Effect of C-collar in Optic Nerve Sheath Diameter
Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes
Overall Study
STARTED
50
Overall Study
COMPLETED
50
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Effect of C-collar in Optic Nerve Sheath Diameter
n=50 Participants
Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes
Age, Categorical
<=18 years
0 Participants
n=50 Participants
Age, Categorical
Between 18 and 65 years
50 Participants
n=50 Participants
Age, Categorical
>=65 years
0 Participants
n=50 Participants
Age, Continuous
39.44 years
STANDARD_DEVIATION 6.56 • n=50 Participants
Sex: Female, Male
Female
20 Participants
n=50 Participants
Sex: Female, Male
Male
30 Participants
n=50 Participants
Region of Enrollment
Turkey
50 participants
n=50 Participants
Optic Nerve Sheath Diameter
4.71 milimeters
STANDARD_DEVIATION 0.22 • n=50 Participants

PRIMARY outcome

Timeframe: 20 minutes

We hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients

Outcome measures

Outcome measures
Measure
Effect of C-collar in Optic Nerve Sheath Diameter
n=50 Participants
Comparing the effect of c-collar in minor head trauma patients by using optic nerve sheath diameter ultrasonography ultrasonography: optic nerve sheath diameter measurement will be done by ultrasonography on both eyes
Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients
20th minute
5.26 Milimeter
Standard Deviation 0.45
Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients
0th Minute
4.71 Milimeter
Standard Deviation 0.22
Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients
5th minute
5.19 Milimeter
Standard Deviation 0.41

Adverse Events

Effect of C-collar in Optic Nerve Sheath Diameter

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sinan KARACABEY

Marmara University

Phone: +902166254545

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place