The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT03988868|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Because the optic nerve is surrounded by the cerebrospinal fluid, increase / decrease in the intracranial pressure can be examined by an increase / decrease in the optic nerve sheath diameter (ONSD). Non-invasive trans-orbital ultrasonography has been used to measure the ONSD and shown to be useful in differentiating patients with increased intracranial pressure (> 20 cmH2O).
Arterial carbon dioxide partial pressure (PaCO2) is closely related to cerebral blood flow. According to the textbook, an increase in PaCO2 in the range of PaCO2 = 25 mmHg to PaCO2 = 75 mmHg can cause a change in intracranial pressure by proportionally increasing cerebral blood flow. Because end-tidal CO2 partial pressure (ETCO2) reflects PaCO2, a significant correlation may be expected between the ETCO2 and the ONSD.
Previous studies in adult patients showed that ONSD was sensitively increased / decreased according to short-term hypercapnia (ETCO2 = 50mmHg) or hypocapnia (ETCO2 = 30mmHg) for 10 minutes and normalized at normal ETCO2 (40mmHg). Therefore, the reactivity of the ONSD according to the change of the ETCO2 was confirmed in adult patients.
In normal pediatric patients, ONSD is expected to respond to changes in ETCO2. However, no previous study has confirmed this. In addition, the reactivity of ONSD was not studied in neonates and infants with open fontanelle.
In this study, the investigators will performed trans-orbital ultrasonography in pediatric patients with normal intracranial intracranial pressure aged 18 years or younger scheduled for surgery under general anesthesia. The ONSD will be measured at three ETCO2 levels; 35mmHg, 40mmHg, and 45mmHg.
|Condition or disease|
Induction of general anesthesia and endotracheal intubation will be performed with standard electrocardiography, non-invasive blood pressure, heart rate, pulse oximetry, and ETCO2 monitoring.
The ONSD will be measured at three different ETCO2 levels (35mmHg, 40mmHg, and 45mmHg). Each ETCO2 levels will be maintained within +-2mmHg for 10 minutes.
A high frequency linear probe will be used to get the images of optic nerve sheath and the diameter (ONSD) will be measured at 3 mm from the papillary segment in the transverse plane. Mean arterial pressure and heart rate will be recorded during ONSD measurements. The open or closure of Fontanelle will be examined after ONSD measurements.
The ONSD and Eyeball size measurements will be performed by two independent researchers who do not participate in ultrasound examination using stored images.
|Study Type :||Observational|
|Estimated Enrollment :||64 participants|
|Official Title:||The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter Measured by a Transorbital Ultrasonography in Pediatric Patients|
|Estimated Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
- Optic nerve sheath diameter [ Time Frame: 1 weeks ]Optic nerve sheath diameter (ONSD) measured at three ETCO2 levels(35mmHg, 40mmHg, and 45mmHg) by transorbital ultrasonography
- Mean arterial pressure [ Time Frame: 1 weeks ]Mean arterial pressure during ONSD measurements
- Heart rate [ Time Frame: 1 weeks ]Heart rate during ONSD measurements
- Eyeball diameter [ Time Frame: 1 weeks ]Eyeball diameter by transorbital ultrasonography
- Open Fontanelle [ Time Frame: 1 weeks ]Open of the Fontanelle by palpation
- Age [ Time Frame: 1 weeks ]Age
- Sex [ Time Frame: 1 weeks ]Sex
- Weight [ Time Frame: 1 weeks ]Weight
- Height [ Time Frame: 1 weeks ]Height
- BMI [ Time Frame: 1 weeks ]BMI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988868
|Contact: Jin-Tae Kim, MD.PhD.||firstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital||Not yet recruiting|
|Seoul, Korea, Republic of, 03080|
|Contact: Jin-Tae Kim, MD. PhD. 82-2-2072-3664 email@example.com|
|Principal Investigator:||Jin-Tae Kim, MD.PhD.||Professor|