Effect of Raised End-Tidal pCo2 on Choroidal Volume

NCT06275308 | Recruiting

• 1 other identifier: STUDY21100163
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP) (mmHg)

  Measurement of intraocular pressure after maintenance of end tidal pCO2 for 5 minutes at three end tidal pCO2 values : 40mmHg, then 30mmHg and then 50mmHg

  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 measured

Secondary Outcomes (1)

• 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 taken

Study Arms (1)

Observational Group

EXPERIMENTAL

Manipulation of end tidal carbon dioxide in subjects

Other: Ventilation manipulation

Interventions

Ventilation manipulation OTHER

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

Observational Group

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Study Officials

• Amy Monroe, MPH, MBA

  University of Pittsburgh

  STUDY DIRECTOR

• Kanwal Nischal, MD,FRCOphth

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

412-623-6382; monroeal@upmc.edu

Alisha Maslanka, BS, CCRC

CONTACT

412-491-2748; alisha.maslanka@chp.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a descriptive case series.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 23, 2024
• Study Start: February 27, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)