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Effects of Intubation on Intra-ocular Pressure and Optic Nerve Sheath Diameter

Comparison of the Effects of Intubation With a Machintosh Laryngoscope, McGrath Videolaryngoscope and C-Mac Videolaryngoscope on Intra-ocular Pressure, Optic Nerve Sheath Diameter and Haemodynamic Parameters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05763056
Acronym
[Intubation]
Enrollment
120
Registered
2023-03-10
Start date
2023-09-01
Completion date
2023-11-08
Last updated
2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure

Keywords

laryngoscope, intraocular pressure, optic nerve sheath

Brief summary

Brief Summary: In this study, the investigators aimed to compare the effects of different types of endotracheal instruments (Machintosh laryngoscope, McGrath videoingoscope and C-Mac videoryngoscope) on intraocular pressure, optic nerve diameter and hemodynamic parameters.

Detailed description

Detailed Description: Laryngoscopy and endotracheal intubation cause increased intracranial pressure due to hypoxia, hypercapnia, straining, or coughing. It may be an indirect result of increased arterial and venous pressure, as well as a direct effect of intubation. With the emergence of neuroimaging techniques and new diagnostic tools, various methods have been developed that can replace invasive methods, which are the gold standard in intraocular pressure measurement. However, invasive methods such as intraventricular and intraparenchymal catheter systems have some disadvantages and are associated with significant risks in terms of infection, bleeding, and time lost until follow-up. The intraorbital subarachnoid space surrounding the optic nerve shows the same pressure variation as the intracranial subarachnoid space, and any increase in intracranial pressure is also seen in the orbital subarachnoid space. With the increase in intracranial pressure, the optic nerve, optic nerve sheath diameter, and subarachnoid space enlarge. There are many studies reporting that optic nerve sheath diameter can be evaluated using ultrasonography. Although there is no clear cut-off value for optic nerve sheath diameter, previous studies have found that an optic nerve sheath diameter of 5.0 mm and above may indicate an increase in intracranial pressure. Previous studies have determined that the distribution of intraocular pressure in the adult population varies between 11 mmHg and 21 mmHg, and the mean intraocular pressure is 16.5 mmHg. It is well known that the sympathoadrenergic response caused by laryngoscopy and tracheal intubation significantly increases intraocular pressure (at least 10-20 mmHg). In addition, intravenous pressure and intraocular pressure increase due to cough, airway obstruction, succinylcholine use, hypoxia and hypercapnia during intubation. In this study, the investigators aimed to compare the effects of different types of endotracheal instruments (Machintosh laryngoscope, McGrath videoingoscope and C-Mac videoringoscope) on intraocular pressure, optic nerve sheath diameter and hemodynamic parameters.

Interventions

The McGrath video laryngoscope has a thin, disposable, clear, regularly shaped blade similar to a Macintosh blade and a large LCD display attached to the arm. It is lighter in weight and the Mc VL has a small camera at the tip, with a more compact screen and handle that can make tracheal intubation easier and faster in normal or difficult airway. The smaller volume, thinner and portrait screen helps reduce blind spots

PROCEDUREC-MAC videolaryngoscopy

The Macintosh blade is attached to the handle and the light beam is passed through the blade tip into a small metal guide tube indented 40 mm. The camera cable is connected to the control unit and the optical cable is connected to the light source. The video macintosh system is installed in a small trolley for easy portability of the device. The trolley supports an 8-inch monitor mounted on a rotating arm on the patient's left side. C-MAC VL devices can create continuous video recordings or static images on a secure removable digital card. The electronic module includes 2 buttons for photo and video shooting. In addition, the image of the C-MAC VL device can be viewed on other devices or recorded via a standard video output port. 3 C-MAC VL reusable metal macintosh blades (sizes 2 to 4) can be used for adult patients. These non-disposable knives have a closed design without gaps in terms of hygiene and have beveled edges to prevent tissue damage.

DEVICEDirect laryngoscopy

During intubation with a direct laryngoscope (DL), the laryngoscope is inserted into the oral cavity from the right side of the mouth, the tongue is pushed to the left, and after advancing up to the vallecula, it hangs up and forward. In this way, the floor of the mouth and the epiglottis structure are removed from the field of view. If a straight blade laryngoscope is to be used, it is advanced so that the epiglottis remains under the blade after viewing the epiglottis (1). In DL, manipulations such as head extension, sniffing position, and compression of the cricoid cartilage may be required to facilitate visualization of the vocal folds. In 10-15% of the complications experienced during intubation with DL, there are problems related to the angle of view.

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Single (Participant)

Intervention model description

Parallel Assignment Prospective Randomized, Placebo-Controlled Clinical Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Non-ophthalmic surgery * Mallampati I or II classifications * American Society of Anesthesiologists (ASA) I-II

Exclusion criteria

* Glaucoma, * Diabetes mellitus, * Cardiovascular diseases, * Pulmonary diseases, * ASA 3 and 4 * Body Mass Index (BMI) greater than 30 * Eye surgery * Difficult intubation (Mallampati score of 3 or 4, thyromental distance of less than 6 cm and a maximum mouth opening of less than 3 cm) * Intraocular pressure value more than 20 mmHg * More than two intubation attempts * A risk of regurgitation patients * History of obstetric surgery * Allergies to propofol, fentanyl or rocuronium

Design outcomes

Primary

MeasureTime frameDescription
Intraocular pressure-5Intraocular pressure will be measured at 10 minutes after intubationRight and left intraocular pressures will be measured with a Tono-pen (AVIA) (Reichert Technologies, Depew, NY, USA) device by an ophthalmologist unaware of the patient group. Initial intraocular pressure value will measured without using any sedative drugs. An ophthalmologist, unaware of the randomization, measured intraocular pressure using ocular sonography. It will be measured as intraocular pressure: mmHg.
Intraocular pressure-1Intraocular pressure will be measured at before inductionRight and left intraocular pressures will be measured with a Tono-pen (AVIA) (Reichert Technologies, Depew, NY, USA) device by an ophthalmologist unaware of the patient group. Initial intraocular pressure value will measured without using any sedative drugs. An ophthalmologist, unaware of the randomization, measured intraocular pressure using ocular sonography. It will be measured as intraocular pressure: mmHg.
Intraocular pressure-2Intraocular pressure will be measured at just before laryngoscopy and intubationRight and left intraocular pressures will be measured with a Tono-pen (AVIA) (Reichert Technologies, Depew, NY, USA) device by an ophthalmologist unaware of the patient group. Initial intraocular pressure value will measured without using any sedative drugs. An ophthalmologist, unaware of the randomization, measured intraocular pressure using ocular sonography. It will be measured as intraocular pressure: mmHg.
Intraocular pressure-3Intraocular pressure will be measured at immediately after intubationRight and left intraocular pressures will be measured with a Tono-pen (AVIA) (Reichert Technologies, Depew, NY, USA) device by an ophthalmologist unaware of the patient group. Initial intraocular pressure value will measured without using any sedative drugs. An ophthalmologist, unaware of the randomization, measured intraocular pressure using ocular sonography. It will be measured as intraocular pressure: mmHg.
Intraocular pressure-4Intraocular pressure will be measured at 5 minutes after intubationRight and left intraocular pressures will be measured with a Tono-pen (AVIA) (Reichert Technologies, Depew, NY, USA) device by an ophthalmologist unaware of the patient group. Initial intraocular pressure value will measured without using any sedative drugs. An ophthalmologist, unaware of the randomization, measured intraocular pressure using ocular sonography. It will be measured as intraocular pressure: mmHg.

Secondary

MeasureTime frameDescription
Optic nerve diameter measurement-1Optic nerve diameter measurement-1 will be measured at before inductionOptic nerve diameter measurements will be made from the transverse and sagittal planes of both eyes using a linear 6-12 MHz transducer (EsaoteMyLabFive, Genoa, Italy). An ophthalmologist, unaware of the randomization, measured optic nerve diameter using ocular sonography. It will be measured as optic nerve sheath diameter: mm.
Optic nerve diameter measurement-2Optic nerve diameter measurement-2 will be measured at just before laryngoscopy and intubationOptic nerve diameter measurements will be made from the transverse and sagittal planes of both eyes using a linear 6-12 MHz transducer (EsaoteMyLabFive, Genoa, Italy). An ophthalmologist, unaware of the randomization, measured optic nerve diameter using ocular sonography. It will be measured as optic nerve sheath diameter: mm.
Optic nerve diameter measurement-3Optic nerve diameter measurement-3 will be measured at immediately after intubationOptic nerve diameter measurements will be made from the transverse and sagittal planes of both eyes using a linear 6-12 MHz transducer (EsaoteMyLabFive, Genoa, Italy). An ophthalmologist, unaware of the randomization, measured optic nerve diameter using ocular sonography. It will be measured as optic nerve sheath diameter: mm.
Optic nerve diameter measurement-4Optic nerve diameter measurement-4 will be measured at 5 minutes after intubationOptic nerve diameter measurements will be made from the transverse and sagittal planes of both eyes using a linear 6-12 MHz transducer (EsaoteMyLabFive, Genoa, Italy). An ophthalmologist, unaware of the randomization, measured optic nerve diameter using ocular sonography. It will be measured as optic nerve sheath diameter: mm.
Optic nerve diameter measurement-5Optic nerve diameter measurement-5 will be measured at 10 minutes after intubationOptic nerve diameter measurements will be made from the transverse and sagittal planes of both eyes using a linear 6-12 MHz transducer (EsaoteMyLabFive, Genoa, Italy). An ophthalmologist, unaware of the randomization, measured optic nerve diameter using ocular sonography. It will be measured as optic nerve sheath diameter: mm.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026