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
| 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
| 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 minutesWe hypothesised that optic nerve sheath diameter raises after c-collar application in minor head trauma patients
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place