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

NCT03988868 | Completed

• 1 other identifier: H-1904-053-1027
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, General

Keywords

optic nerve sheath diameter; end-tidal carbon dioxide; trans-orbital ultrasonography

Outcome Measures

Primary Outcomes (1)

• Optic nerve sheath diameter

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

  1 weeks

Secondary Outcomes (9)

• Mean arterial pressure

  1 weeks

• Heart rate

  1 weeks

• Eyeball diameter

  1 weeks

• Open Fontanelle

  1 weeks

• Age

  1 weeks

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Children under 18 years of age who are under general anesthesia
• Mechanical ventilation by endotracheal intubation
• Supine position during surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (3)

• Le A, Hoehn ME, Smith ME, Spentzas T, Schlappy D, Pershad J. Bedside sonographic measurement of optic nerve sheath diameter as a predictor of increased intracranial pressure in children. Ann Emerg Med. 2009 Jun;53(6):785-91. doi: 10.1016/j.annemergmed.2008.11.025. Epub 2009 Jan 23.

  PMID: 19167786 BACKGROUND

• Wang LJ, Chen LM, Chen Y, Bao LY, Zheng NN, Wang YZ, Xing YQ. Ultrasonography Assessments of Optic Nerve Sheath Diameter as a Noninvasive and Dynamic Method of Detecting Changes in Intracranial Pressure. JAMA Ophthalmol. 2018 Mar 1;136(3):250-256. doi: 10.1001/jamaophthalmol.2017.6560.

  PMID: 29392301 BACKGROUND

• Dinsmore M, Han JS, Fisher JA, Chan VW, Venkatraghavan L. Effects of acute controlled changes in end-tidal carbon dioxide on the diameter of the optic nerve sheath: a transorbital ultrasonographic study in healthy volunteers. Anaesthesia. 2017 May;72(5):618-623. doi: 10.1111/anae.13784. Epub 2017 Feb 8.

  PMID: 28177116 BACKGROUND

Study Officials

• Jin-Tae Kim, MD.PhD.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 18, 2019
• Study Start: June 19, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)