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

NCT05763056 | Completed

• 1 other identifier: ekaraaslan4
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure

Keywords

laryngoscope; intraocular pressure; optic nerve sheath

Outcome Measures

Primary Outcomes (5)

• Intraocular pressure-1

  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 will be measured at before induction

• Intraocular pressure-2

  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 will be measured at just before laryngoscopy and intubation

• Intraocular pressure-3

  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 will be measured at immediately after intubation

• Intraocular pressure-4

  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 will be measured at 5 minutes after intubation

• Intraocular pressure-5

  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 will be measured at 10 minutes after intubation

Secondary Outcomes (5)

• Optic nerve diameter measurement-1

  Optic nerve diameter measurement-1 will be measured at before induction

• Optic nerve diameter measurement-2

  Optic nerve diameter measurement-2 will be measured at just before laryngoscopy and 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-5

  Optic nerve diameter measurement-5 will be measured at 10 minutes after intubation

Study Arms (3)

McGrath videolaryngoscopy

ACTIVE COMPARATOR

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.

Procedure: McGrath videolaryngoscopy; Procedure: C-MAC videolaryngoscopy; Device: Direct laryngoscopy

C-MAC videolaryngoscopy

ACTIVE COMPARATOR

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

Procedure: McGrath videolaryngoscopy; Procedure: C-MAC videolaryngoscopy; Device: Direct laryngoscopy

Direct laryngoscopy

ACTIVE COMPARATOR

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.

Procedure: McGrath videolaryngoscopy; Procedure: C-MAC videolaryngoscopy; Device: Direct laryngoscopy

Interventions

McGrath videolaryngoscopy PROCEDURE

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

C-MAC videolaryngoscopy; Direct laryngoscopy; McGrath videolaryngoscopy

C-MAC videolaryngoscopy PROCEDURE

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.

C-MAC videolaryngoscopy; Direct laryngoscopy; McGrath videolaryngoscopy

Direct laryngoscopy DEVICE

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.

C-MAC videolaryngoscopy; Direct laryngoscopy; McGrath videolaryngoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Medical Faculty

Malatya, 44090, Turkey (Türkiye)

Location

Related Publications (1)

• Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.

  PMID: 21505900 BACKGROUND

Study Officials

• Erol Karaaslan, assoc prof

  Inonu University Medical Faculty , malatya.turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single (Participant)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment Prospective Randomized, Placebo-Controlled Clinical Trial

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: March 10, 2023
• Study Start: September 1, 2023
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)