Cleft PalateNCT04718558
Optic Nerve Sheath Diameter Measurement in Cleft Palate Repair
An observational study of Cleft Palate, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 24 months
- Conditions the study is for
- Cleft Palate
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Jul 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cleft Palate
- Keywords
- optic nerve sheat diameter, mouth gag, cleft palate, ultrasonography
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged between 3-24 month and undergoing cleft palate surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Change in heart rate by using electrocardiogram on the anesthesia workstation
Measured: 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
Measured: 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
Measured: After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Oct 2020
- Primary completion15 May 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AKDOĞAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718558
- Sponsor's protocol ID
- 2020/271
- Status last verified
- Nov 2021
- First submitted
- 16 Jan 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Boyle-Davis Mouth Gape on Intracranial Pressure in Patients With Cleft Palate Repair by Measuring Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT04718558
- Acronym / sponsor ID
- 2020/271
- Conditions
- Cleft Palate
- Keywords
- optic nerve sheat diameter, mouth gag, cleft palate, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged between 3-24 month and undergoing cleft palate surgery | – | – |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in optic nerve sheath diameter
Time frame: 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 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
3 secondary outcomes
Change in heart rate
Time frame: 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
Time frame: 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
Time frame: After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
Related trials for Cleft Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Not yet recruiting
Furlow With Buccinator and Fistula Formation
Cleft Palate
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in optic nerve sheath diameter (time frame: After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.