Modification of the Stylet Shape of the Glidescope for Facilitating Difficult Intubation

Efficacy of Lubricating the Under Surface of Glidescope Blade Stylet Shape Modification to Facilitate Endotracheal Intubation for Suspected Difficult Intubation; A Prospective Randomized Controlled Trial

The undersurface of the disposable blade of the Glidescope will be lubricated by a jelly substance to facilitate its entrance to the mouth without trauma to the soft tissues. In addition the stylet ( Gliderite) shape will be modified to be an obtuse angle. This technique modification will be applied for obese patients with suspected difficult intubation criteria who are scheduled for bariatric surgeries.

Study Overview

• Status: Not yet recruiting
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: Gliderite® shape modification

Detailed Description

Endotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light.

The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff.

If during intubation the used technique failed to introduce the tube, we will do ETT rotation inside the mouth or upward stylet angulation outside the mouth then will be reintroduced again. If Glidescope failed to intubate, we will use intubating LMA to intubate the patients. If all trials failed to intubate the patients. Sugamadex 16 mg/Kg will be injected to awaken the patients. After intubation the large gastric tube will be introduced in the esophagus under vision by the Glidescope help also.

Group 2:

The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabah Ayoub, MD; Phone Number: 563887242 966563887242; Email: sabah_nageeb@med.asu.edu.eg
• Study Contact Backup: Name: Rabah Alharbi, Saudi board; Phone Number: 0555595373 9660555595373; Email: rabahsa@moh.gov.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status II or III
• BMI more than 35
• Patients presenting with at least one predictor for a difficult airway.
• The airway difficulty is at least score 3 as an indicator of difficulty.

Exclusion Criteria:

• Patients who may need rapid sequence induction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stylet shape modification group; Endotracheal tube diameter size 7.5 mm and disposable rigid blade size 3 for the female patients and ETT diameter size 8.00 mm and disposable rigid blade size 4 for the male patients will be prepared. The under surface of the blade will be lubricated by soluble jelly, taking care not to touch the camera source of light. The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis. Once the tip of the tube introduced inside the glottis, the stylet will be removed and the tube will be advanced more inside the trachea. The equality of air entry will be assessed by the stethoscope and the tube will by fixed by adhesive tape after inflating the cuff.	Device: Gliderite® shape modification; The stylet will be more obtuse angle than the standard shape. The stylet will be lubricated also before being fitted inside the endotracheal tube. The blade will be introduced inside the mouth midline, the tube will be held from the upper third and introduced in the midline also sliding over the blade and introduced inside the glottis.; Other Names: Lubrication of the disposable blade by a jelly substance
No Intervention: Standard shape of the stylet group; The second group will be a control group, they will be handled by the standard shape of the stylet and the blade without lubrication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time in seconds	the intubation time will be calculated in seconds from the video screen of the Glidescope watch	intraoperative time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of trials of endotracheal intubation	the intubation time will be recorded	intraoperative time
mucosal damage during the intubation	The blade under surface will be observed for blood spots. And the oral cavity will be viewed for mucosal damage or obscured view.	intraoperative time

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Sabah Ayoub, MD, ain shams University

Publications and helpful links

Helpful Links

• 5. Ryo Wakabayashi1*, Yuki Shiko2 , Tomofumi Kodaira1 , Yuko Shiroshita1 , Hitomi Otsuka1 , Kosuke Baba1 & Norimasa Hishinuma Efcacy of stylet angulation at the holding position during tracheal intubation with a videolaryngoscope: a randomized controlled

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: difficult intubation; blade lubrication; stylet shape
• Other Study ID Numbers: Glidescope

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No