Optic Nerve Sheath NeoplasmNCT05445271
Optic Nerve Sheath Diameter in Pediatric Patients
A study testing Optic nerve sheath diameter measurement with linear ultrasound in people with Optic Nerve Sheath Neoplasm and Intracranial Pressure Increase, run by Kahramanmaras Sutcu Imam University.
Trial summary
Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Neoplasm, Intracranial Pressure Increase, Intubation Complication
- What is being tested?
- Optic nerve sheath diameter measurement with linear ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 2-18 years
- Patients undergoing general anesthesia
- Patients who agreed to be included
- ASA I-III
Who cannot join
- Those with any eye pathology
- Those with intracranial pathology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Endotracheal Intubation or Laryngeal Mask Applications on Optic Nerve
Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.
Read the detailed description
In normal pediatric patients with closed fontanelles, the contents of the central nervous system are almost compressed into the skull and spinal canal. Intracranial pressure is created and constant by the total volume of brain, CSF, and blood within the skull. Increased intracranial pressure can be measured with an intraventricular catheter, transducers, and a subarachnoid bolt. By measuring the diameter of the optic nerve sheath with ultrasonography, we can find out whether there is an increase in intracranial pressure non-invasively.
Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.
- Conditions
- Optic Nerve Sheath Neoplasm, Intracranial Pressure Increase, Intubation Complication, Airway Complication of Anesthesia
- Being tested
- Optic nerve sheath diameter measurement with linear ultrasound
- Medical subject headings
- Optic Nerve Neoplasms, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath diameter measurement with linear ultrasoundDiagnostic test
In this study, we aimed to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 30 patients who will be intubated with a video laryngoscope and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). 5 minutes after the patient is intubated with a video laryngoscope, the optic nerve sheath diameter of both eyes is measured and recorded (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded. Receives: Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound |
| Group 2 | Active comparator | 30 patients who will be intubated with a normal laryngoscope and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). 5 minutes after the patient is intubated with a normal laryngoscope, the optic nerve sheath diameter of both eyes is measured and recorded (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded. Receives: Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound |
| Group 3 | Active comparator | 30 patients who will be ventilated with a laryngeal mask airway (LMA) and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). The optic nerve sheath diameter of both eyes is measured and recorded 5 minutes after LMA is placed on the patient (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded. Receives: Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter measurement at pediatric patients
to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve Sheath NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Calisir, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445271
- Sponsor's protocol ID
- 2018/01-28
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Endotracheal Intubation or Laryngeal Mask Applications on Optic Nerve
- ClinicalTrials.gov ID
- NCT05445271
- Acronym / sponsor ID
- 2018/01-28
- Conditions
- Optic Nerve Sheath Neoplasm, Intracranial Pressure Increase, Intubation Complication, Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jul 2022 (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.
Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.
Detailed description
In normal pediatric patients with closed fontanelles, the contents of the central nervous system are almost compressed into the skull and spinal canal. Intracranial pressure is created and constant by the total volume of brain, CSF, and blood within the skull. Increased intracranial pressure can be measured with an intraventricular catheter, transducers, and a subarachnoid bolt. By measuring the diameter of the optic nerve sheath with ultrasonography, we can find out whether there is an increase in intracranial pressure non-invasively.
Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound30 patients who will be intubated with a video laryngoscope and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). 5 minutes after the patient is intubated with a video laryngoscope, the optic nerve sheath diameter of both eyes is measured and recorded (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded. |
| Group 2 | Active comparator | Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound30 patients who will be intubated with a normal laryngoscope and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). 5 minutes after the patient is intubated with a normal laryngoscope, the optic nerve sheath diameter of both eyes is measured and recorded (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded. |
| Group 3 | Active comparator | Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound30 patients who will be ventilated with a laryngeal mask airway (LMA) and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). The optic nerve sheath diameter of both eyes is measured and recorded 5 minutes after LMA is placed on the patient (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients aged 2-18 years
- Patients undergoing general anesthesia
- Patients who agreed to be included
- ASA I-III
Key exclusion criteria (2 listed)
- Those with any eye pathology
- Those with intracranial pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve sheath diameter measurement with linear ultrasoundIn this study, we aimed to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure. | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
Optic nerve sheath diameter measurement at pediatric patients
Time frame: 6 months
to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Optic nerve sheath diameter measurement with linear ultrasound in people with Optic Nerve Sheath Neoplasm and Intracranial Pressure Increase, run by Kahramanmaras Sutcu Imam University.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feyza Calisir (05056492875, fbolcal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic nerve sheath diameter measurement at pediatric patients (time frame: 6 months). 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 6 Jul 2022.