Optic Nerve Sheath Diameter Measurement in Cleft Palate Repair
Evaluation of the Effect of Boyle-Davis Mouth Gape on Intracranial Pressure in Patients With Cleft Palate Repair by Measuring Optic Nerve Sheath Diameter
1 other identifier
observational
30
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of the Boyle-Davis mouth opener, which is routinely used in cleft palate surgery, on intracranial pressure by USG-guided optic nerve sheath diameter measurement, which is a non-invasive method with proven effectiveness and reliability in recent years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedNovember 3, 2021
November 1, 2021
8 months
January 16, 2021
November 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in optic nerve sheath diameter
Change in optic nerve sheath diameter as assessed by rapid ultrasound scan before general anesthesia, after intubation, 1 minute, 10 minutes, 20 minutes, 40 minutes, 60 minutes after mouth gag is inserted and after mouth gape is removed
After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Secondary Outcomes (3)
Change in heart rate
After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Change in End tidal CO2
After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Change in Peak inspiratory pressure (PIP) workstation
After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Study Arms (1)
Patients aged between 3-24 month and undergoing cleft palate surgery
Eligibility Criteria
Patients aged between 3-24 month and with an ASA physical status I-II and undergoing cleft palate surgery will be included to the study
You may qualify if:
- Patients aged between 3-24 month and with an ASA physical status I-II and undergoing cleft palate surgery will be included to the study.
You may not qualify if:
- History of eye surgery, use of drugs known to influence intraocular pressure (IOP) (ß blockers, Ca channel blockers, statins and nitrates)
- Conditions that may cause known intracranial pressure changes (cerebrovascular event, bleeding, an intracranial tumor, etc.)
- patients' parental refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karadeniz Technical University
Trabzon, 61080, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
January 16, 2021
First Posted
January 22, 2021
Study Start
October 1, 2020
Primary Completion
May 15, 2021
Study Completion
July 1, 2021
Last Updated
November 3, 2021
Record last verified: 2021-11