Effects of Intubation on Intra-ocular Pressure and Optic Nerve Sheath Diameter
- Conditions
- Intraocular Pressure
- Interventions
- Procedure: McGrath videolaryngoscopyProcedure: C-MAC videolaryngoscopyDevice: Direct laryngoscopy
- Registration Number
- NCT05763056
- Lead Sponsor
- Inonu University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Non-ophthalmic surgery
- Mallampati I or II classifications
- American Society of Anesthesiologists (ASA) I-II
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Direct laryngoscopy Direct laryngoscopy Macintosh laryngoscopy is still one of the most commonly used advanced airway methods today. For an ideal glottis view in direct laryngoscopy, the mouth and larynx should be in alignment. For this, longitudinal flexion and head extension maneuvers are performed. Reasons such as the clinical situation during intubation and the anatomical variation in the patient may prevent this maneuver from being performed. McGrath videolaryngoscopy Direct laryngoscopy It is a portable videoryngoscope weighing only 325 grams. The CameraStickTM component consists of a light source and a miniature camera, and the image is displayed on a 1.7 inch LCD (Liquid Crystal Display) screen mounted on top of the laryngoscope handle. At the same time, the LCD screen maintains visual contact with the patient and the laryngoscope, can be rotated up to 90°, allowing the user to work in a comfortable posture while performing tracheal intubation. The blade length is suitable for children over 5 years old and adults, thus reducing the trouble of storing different sized blades in the emergency intubation trolley. The blades are sterile and there is no risk of contamination as they are disposable. C-MAC videolaryngoscopy C-MAC videolaryngoscopy Considering the importance of first attempt success in intubation, their use in emergency airway management has increased due to the high first attempt success rate in C-MAC VLs. In patients with cervical spine injury, semi-rigid collars used to prevent neck extension and neck movements cause poor laryngeal vision with Direct laryngoscope and difficulty intubation. C-MAC Video laryngoscope provides a better laryngeal view in these patients McGrath videolaryngoscopy C-MAC videolaryngoscopy It is a portable videoryngoscope weighing only 325 grams. The CameraStickTM component consists of a light source and a miniature camera, and the image is displayed on a 1.7 inch LCD (Liquid Crystal Display) screen mounted on top of the laryngoscope handle. At the same time, the LCD screen maintains visual contact with the patient and the laryngoscope, can be rotated up to 90°, allowing the user to work in a comfortable posture while performing tracheal intubation. The blade length is suitable for children over 5 years old and adults, thus reducing the trouble of storing different sized blades in the emergency intubation trolley. The blades are sterile and there is no risk of contamination as they are disposable. Direct laryngoscopy C-MAC videolaryngoscopy Macintosh laryngoscopy is still one of the most commonly used advanced airway methods today. For an ideal glottis view in direct laryngoscopy, the mouth and larynx should be in alignment. For this, longitudinal flexion and head extension maneuvers are performed. Reasons such as the clinical situation during intubation and the anatomical variation in the patient may prevent this maneuver from being performed. McGrath videolaryngoscopy McGrath videolaryngoscopy It is a portable videoryngoscope weighing only 325 grams. The CameraStickTM component consists of a light source and a miniature camera, and the image is displayed on a 1.7 inch LCD (Liquid Crystal Display) screen mounted on top of the laryngoscope handle. At the same time, the LCD screen maintains visual contact with the patient and the laryngoscope, can be rotated up to 90°, allowing the user to work in a comfortable posture while performing tracheal intubation. The blade length is suitable for children over 5 years old and adults, thus reducing the trouble of storing different sized blades in the emergency intubation trolley. The blades are sterile and there is no risk of contamination as they are disposable. Direct laryngoscopy McGrath videolaryngoscopy Macintosh laryngoscopy is still one of the most commonly used advanced airway methods today. For an ideal glottis view in direct laryngoscopy, the mouth and larynx should be in alignment. For this, longitudinal flexion and head extension maneuvers are performed. Reasons such as the clinical situation during intubation and the anatomical variation in the patient may prevent this maneuver from being performed. C-MAC videolaryngoscopy McGrath videolaryngoscopy Considering the importance of first attempt success in intubation, their use in emergency airway management has increased due to the high first attempt success rate in C-MAC VLs. In patients with cervical spine injury, semi-rigid collars used to prevent neck extension and neck movements cause poor laryngeal vision with Direct laryngoscope and difficulty intubation. C-MAC Video laryngoscope provides a better laryngeal view in these patients C-MAC videolaryngoscopy Direct laryngoscopy Considering the importance of first attempt success in intubation, their use in emergency airway management has increased due to the high first attempt success rate in C-MAC VLs. In patients with cervical spine injury, semi-rigid collars used to prevent neck extension and neck movements cause poor laryngeal vision with Direct laryngoscope and difficulty intubation. C-MAC Video laryngoscope provides a better laryngeal view in these patients
- Primary Outcome Measures
Name Time Method Intraocular pressure-5 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 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 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 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 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 Outcome Measures
Name Time Method Optic nerve diameter measurement-2 Optic nerve diameter measurement-2 will be measured at just before laryngoscopy and intubation Optic 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-5 Optic nerve diameter measurement-5 will be measured at 10 minutes after intubation Optic 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-3 Optic nerve diameter measurement-3 will be measured at immediately after intubation Optic 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-4 Optic nerve diameter measurement-4 will be measured at 5 minutes after intubation Optic 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-1 Optic nerve diameter measurement-1 will be measured at before induction Optic 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.
Trial Locations
- Locations (1)
Inonu University Medical Faculty
🇹🇷Malatya, Turkey