Anesthesia, GeneralNCT03988868
The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter in Pediatric Patients
An observational study of Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anesthesia, General
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2019to 3 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- Children under 18 years of age who are under general anesthesia
- Mechanical ventilation by endotracheal intubation
- Supine position during surgery
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter Measured by a Transorbital Ultrasonography in Pediatric Patients
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.
Read more
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.
Read the 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.
- Conditions
- Anesthesia, General
- Keywords
- optic nerve sheath diameter, end-tidal carbon dioxide, trans-orbital ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
Optic nerve sheath diameter (ONSD) measured at three ETCO2 levels(35mmHg, 40mmHg, and 45mmHg) by transorbital ultrasonography
Measured: 1 weeks
Secondary outcomes (9)
Mean arterial pressure
Mean arterial pressure during ONSD measurements
Measured: 1 weeks
Heart rate
Heart rate during ONSD measurements
Measured: 1 weeks
Eyeball diameter
Eyeball diameter by transorbital ultrasonography
Measured: 1 weeks
Open Fontanelle
Open of the Fontanelle by palpation
Measured: 1 weeks
Age
Age
Measured: 1 weeks
Sex
Sex
Measured: 1 weeks
Weight
Weight
Measured: 1 weeks
Height
Height
Measured: 1 weeks
BMI
BMI
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start19 Jun 2019
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD.PhD., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988868
- Sponsor's protocol ID
- H-1904-053-1027
- Status last verified
- Dec 2020
- First submitted
- 12 Jun 2019
- Last updated
- 28 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19167786Wang 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.
PubMed 29392301Dinsmore 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.
PubMed 28177116
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of End-tidal Carbon Dioxide Level on the Optic Nerve Sheath Diameter Measured by a Transorbital Ultrasonography in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03988868
- Acronym / sponsor ID
- H-1904-053-1027
- Conditions
- Anesthesia, General
- Keywords
- optic nerve sheath diameter, end-tidal carbon dioxide, trans-orbital ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Children under 18 years of age who are under general anesthesia
- Mechanical ventilation by endotracheal intubation
- Supine position during surgery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
Mean arterial pressure
Time frame: 1 weeks
Heart rate
Time frame: 1 weeks
Eyeball diameter
Time frame: 1 weeks
Open Fontanelle
Time frame: 1 weeks
Age
Time frame: 1 weeks
Sex
Time frame: 1 weeks
Weight
Time frame: 1 weeks
Height
Time frame: 1 weeks
BMI
Time frame: 1 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Background: PubMed 19167786Le 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.
- Background: PubMed 29392301Wang 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.
- Background: PubMed 28177116Dinsmore 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Tae Kim, MD.PhD. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter (time frame: 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03988868, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.