The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter in Pediatric Patients

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03988868
Collaborator
(none)
64
1
9.5
6.7

Study Details

Study Description

Brief Summary

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 Intervention/Treatment Phase

    Detailed Description

    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 3 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 OND measurements will be performed by two independent researchers who do not participate in ultrasound examination using stored images.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    64 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter Measured by a Transorbital Ultrasonography in Pediatric Patients
    Actual Study Start Date :
    Jun 19, 2019
    Actual Primary Completion Date :
    Apr 3, 2020
    Actual Study Completion Date :
    Apr 3, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Optic nerve sheath diameter [1 weeks]

      Optic nerve sheath diameter (ONSD) measured at three ETCO2 levels(35mmHg, 40mmHg, and 45mmHg) by transorbital ultrasonography

    Secondary Outcome Measures

    1. Mean arterial pressure [1 weeks]

      Mean arterial pressure during ONSD measurements

    2. Heart rate [1 weeks]

      Heart rate during ONSD measurements

    3. Eyeball diameter [1 weeks]

      Eyeball diameter by transorbital ultrasonography

    4. Open Fontanelle [1 weeks]

      Open of the Fontanelle by palpation

    5. Age [1 weeks]

      Age

    6. Sex [1 weeks]

      Sex

    7. Weight [1 weeks]

      Weight

    8. Height [1 weeks]

      Height

    9. BMI [1 weeks]

      BMI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Children under 18 years of age who are under general anesthesia

    • Mechanical ventilation by endotracheal intubation

    • Supine position during surgery

    Exclusion Criteria:
    • Disease including eyeball or orbit

    • Infection or trauma around the eyes

    • Difficult to access the eyes during surgery (Ophthalmologic surgery, neurosurgery, otorhinolaryngology surgery, etc.)

    • Patients with abnormal intracranial pressure abnormality (trauma, brain tumors, hydrocephalus, intracranial pressure control shunt, craniosynostosis..)

    • Laparoscopic surgery, Thoracoscopic surgery

    • Cerebrovascular disease such as Moyamoya disease

    • Hypotension

    • Atelectasis, pneumothorax, pleural effusion, pneumonia, wheezing or crackle before surgery

    • History of adverse reaction to ultrasound gel or Tegaderm (3M Canada, London, Ont., Canada) for eyeball protection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, MD.PhD., Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jin-Tae Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03988868
    Other Study ID Numbers:
    • H-1904-053-1027
    First Posted:
    Jun 18, 2019
    Last Update Posted:
    Dec 28, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jin-Tae Kim, Professor, Seoul National University Hospital

    Study Results

    No Results Posted as of Dec 28, 2020