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Clinical Trials/NCT05763056
NCT05763056CompletedNot Applicable

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

Inonu University2 sites in 1 country120 target enrollmentStarted: September 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
Intraocular pressure-5

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Intraocular pressure-5

Time Frame: Intraocular pressure will be measured at 10 minutes after intubation

Right 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-2

Time Frame: Intraocular pressure will be measured at just before laryngoscopy and intubation

Right 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-3

Time Frame: Intraocular pressure will be measured at immediately after intubation

Right 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-1

Time Frame: Intraocular pressure will be measured at before induction

Right 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-4

Time Frame: Intraocular pressure will be measured at 5 minutes after intubation

Right 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 Outcomes

  • Optic nerve diameter measurement-2(Optic nerve diameter measurement-2 will be measured at just before laryngoscopy and intubation)
  • Optic nerve diameter measurement-5(Optic nerve diameter measurement-5 will be measured at 10 minutes after intubation)
  • Optic nerve diameter measurement-3(Optic nerve diameter measurement-3 will be measured at immediately after intubation)
  • Optic nerve diameter measurement-4(Optic nerve diameter measurement-4 will be measured at 5 minutes after intubation)
  • Optic nerve diameter measurement-1(Optic nerve diameter measurement-1 will be measured at before induction)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Erol Karaaslan

Associate Professor

Inonu University

Study Sites (2)

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