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

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate

Detailed Description

Non-syndromic cleft lip and / or palate is a complex congenital defect that results from multiple genetic and environmental factors. It is also one of the most common congenital malformations. Cleft defects require early surgical repair to minimize nutritional difficulties and ensure optimum speech function. The Boyle-Davis mouth opener used in cleft palate surgery consists of tongue blade, mouth opener and suspension system and is used to fix the endotracheal tube in the midline and provide excellent surgical vision during the operation. However, it can cause complications such as dental injuries, laryngospasm, and displacement of the tracheal tube.

Undesirable effects such as changes in heart rate and increases in intracranial pressures may occur during endotracheal intubation. These hemodynamic responses are thought to be due to increased sympathoadrenal activity. Laryngoscopy without tracheal intubation has been shown to increase high catecholamine levels and blood pressure, suggesting that sympathoadrenergic response occurs more frequently due to stimulation of the supraglottic region. Although the Boyle-Davis mouth opener provides an advantage for access to the intraoral cavity, its insertion causes significant increases in intracranial pressure (ICP) and intraocular pressures by causing hemodynamic changes similar to laryngoscopy.

In recent studies, measurement of optic nerve sheath diameter with ultrasonography, which is a non-invasive method, is frequently used in the detection of intracranial pressure increases. The optic nerve is a part of the central nervous system and is covered with a dural sheath. Pressure changes in the intracranial region are similar to the pressure in the infraorbital subarachnoid space surrounding the optic nerve. In clinical studies, it has been shown that changes in intracranial pressure correlate with the optic nerve sheath diameter measured by ultrasonography. Compared to other diagnostic methods, measurement of the diameter of the optic nerve sheath is an inexpensive, easy-to-apply and non-invasive method. In our study, we aimed to determine the intracranial pressure changes that may occur due to the use of mouth gag in cleft palate surgeries by measuring the optic nerve sheath diameter with USG, which is a non-invasive method.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 61080
    • Karadeniz Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion 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.

Exclusion Criteria:

• Exclusion criteria will be preexisting acute or chronic eye disease,
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients aged between 3-24 month and undergoing cleft palate surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Change in heart rate by using electrocardiogram on the anesthesia workstation	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	Change in End tidal CO2 by using capnography on the anesthesia workstation	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	Change in Peak inspiratory pressure (PIP) by using monitoring on the anesthesia	After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion

Collaborators and Investigators

• Sponsor: Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 15, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: cleft palate; ultrasonography; optic nerve sheat diameter; mouth gag
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: 2020/271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No