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Effect of Raised End-Tidal pCo2 on Choroidal Volume

Effect of Raised End-Tidal pCo2 on Choroidal Volume

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06275308
Enrollment
20
Registered
2024-02-23
Start date
2023-02-27
Completion date
2026-12-30
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Brief summary

This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia.

Detailed description

Children with normal eyes undergoing an exam under anesthesia or a non-intraocular eye procedure will have one eye examined after research consent is taken. Children have very elastic ocular tissues. When they are having an intraocular procedure positive vitreous pressure can cause the iris to prolapse out of the eye and this can cause intraoperative and postoperative complications. The causes of the positive vitreous pressure have been speculated to be due to an increase in choroidal volume. The Choroid is a layer of blood vessels sitting between the sclera and the retina. Ocular Coherence Tomography (OCT) is an imaging tool that allows an optical section of the retina, choroid and sclera to be examined. The subfoveal choroidal thickness has been shown to be a consistent area that can be measured with reliability that the anatomical site of measurement is consistent. By varying the end tidal CO2 the thickness of the choroid will be measured and at the same time the intraocular pressure taken using a pneumatonometer. The OCT is integrated into the operating microscope and is used to take a scan of the fovea. Three scans will be taken after 5minutes of the particular end tidal pCO2. In order to ensure the choroidal thickness is not being influenced by the axial length of the eye, the axial length will be measured using an ultrasound probe at the beginning of the measurements just once. In order to ensure that the position of the head and body is not influencing the choroidal thickness a spirit level will be used to ensure a flat operating bed at the beginning of the measurements.

Interventions

OTHERVentilation manipulation

Effects of ventilation manipulation to achieve desired levels of end tidal carbon dioxide

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

This is a descriptive case series.

Eligibility

Sex/Gender
ALL
Age
No minimum to 8 Years
Healthy volunteers
Yes

Inclusion criteria

* any child undergoing an eye exam under anesthesia for an ophthalmologic reason. * children between the ages newborn to 8 years of age.

Exclusion criteria

* children who are not having an eye exam under anesthesia. * children with a known medical diagnosis that affect the eye to be studied * \* children over the age of 8 years of age. * \* children with altered cerebral autoregulation, increased intracranial pressure, pulmonary hypertension, or any other condition deemed appropriate by the anesthesiologist. * children in whom a laryngeal mask airway will not be used

Design outcomes

Primary

MeasureTime frameDescription
Intraocular Pressure (IOP) (mmHg)After induction of anesthesia end tidal CO2 will be manipulated to 40mmHg, then 30mmHg and then 50mmHg. The end tidal CO2 levels will be held for at least 5 minutes after each ventilation manipulation and at the end of this 5 minute period IOP measuredMeasurement of intraocular pressure after maintenance of end tidal pCO2 for 5 minutes at three end tidal pCO2 values : 40mmHg, then 30mmHg and then 50mmHg

Secondary

MeasureTime frameDescription
Choroidal thickness ( microns)After induction of anesthesia end tidal CO2 will be manipulated to 40mmHg, then 30mmHg and then 50mmHg. The end tidal CO2 levels will be held for at least 5 minutes after each ventilation manipulation;at the end of 5 minute period choroid images takenAfter 5 minutes of maintenance of end tidal pCO2 at 40mmHg, then 30mmHg and then 50mmHg, ocular coherence tomography (OCT) will be used to capture the subfoveal choroid. The images of the choroid will be provided to blinded individuals who will measure their thickness using the integrated scale on the OCT image.

Countries

United States

Contacts

Primary ContactAmy Monroe, MPH, MBA
monroeal@upmc.edu412-623-6382
Backup ContactAlisha Maslanka, BS, CCRC
alisha.maslanka@chp.edu412-491-2748

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026