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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
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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
Anesthesia, General

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 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.


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Study Type : Observational
Estimated 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
Estimated Study Start Date : June 24, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mean arterial pressure [ Time Frame: 1 weeks ]
    Mean arterial pressure during ONSD measurements

  2. Heart rate [ Time Frame: 1 weeks ]
    Heart rate during ONSD measurements

  3. Eyeball diameter [ Time Frame: 1 weeks ]
    Eyeball diameter by transorbital ultrasonography

  4. Open Fontanelle [ Time Frame: 1 weeks ]
    Open of the Fontanelle by palpation

  5. Age [ Time Frame: 1 weeks ]
    Age

  6. Sex [ Time Frame: 1 weeks ]
    Sex

  7. Weight [ Time Frame: 1 weeks ]
    Weight

  8. Height [ Time Frame: 1 weeks ]
    Height

  9. BMI [ Time Frame: 1 weeks ]
    BMI



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All ASA grade I-II pediatric patients with no evidence of increased intracranial pressure under 18 years of either gender undergoing surgery under general anesthesia.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jin-Tae Kim, MD.PhD. 82-2-2072-3664 kimjintae73@gmail.com

Locations
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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    kimjintae73@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, MD.PhD. Professor

Publications:
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03988868     History of Changes
Other Study ID Numbers: H-1904-053-1027
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
optic nerve sheath diameter
end-tidal carbon dioxide
trans-orbital ultrasonography