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出境医 / 临床实验 / The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter in Pediatric Patients

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

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
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 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
Layout table for study information
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 : June 19, 2019
Actual Primary Completion Date : April 3, 2020
Actual Study Completion Date : April 3, 2020
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jin-Tae Kim, MD.PhD. Professor
Tracking Information
First Submitted Date June 12, 2019
First Posted Date June 18, 2019
Last Update Posted Date December 28, 2020
Actual Study Start Date June 19, 2019
Actual Primary Completion Date April 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2019) 		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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 15, 2019)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter in Pediatric Patients
Official Title The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter Measured by a Transorbital Ultrasonography in Pediatric Patients
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Anesthesia, General
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 15, 2019) 		64
Original Estimated Enrollment Same as current
Actual Study Completion Date April 3, 2020
Actual Primary Completion Date April 3, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03988868
Other Study ID Numbers H-1904-053-1027
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jin-Tae Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jin-Tae Kim, MD.PhD. Professor
PRS Account Seoul National University Hospital
Verification Date December 2020

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