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临床试验/NCT06275308
NCT06275308招募中不适用

Effect of Raised End-Tidal pCo2 on Choroidal Volume

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Intraocular Pressure (IOP) (mmHg)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
— 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Observational Group

Experimental

Manipulation of end tidal carbon dioxide in subjects

干预措施: Ventilation manipulation (Other)

结局指标

主要结局

Intraocular Pressure (IOP) (mmHg)

时间窗: 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

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kanwal Nischal

Professor

University of Pittsburgh

研究点 (2)

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