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

NCT05744388 | Unknown

• 1 other identifier: Glidescope
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Difficult Intubation

Keywords

difficult intubation; blade lubrication; stylet shape

Outcome Measures

Primary Outcomes (1)

• Intubation time in seconds

  the intubation time will be calculated in seconds from the video screen of the Glidescope watch

  intraoperative time

Secondary Outcomes (2)

• Number of trials of endotracheal intubation

  intraoperative time

• mucosal damage during the intubation

  intraoperative time

Study Arms (2)

Stylet shape modification group

ACTIVE COMPARATOR

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

Standard shape of the stylet group

NO INTERVENTION

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

Interventions

Gliderite® shape modification DEVICE

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.

Also known as: Lubrication of the disposable blade by a jelly substance

Stylet shape modification group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients who may need rapid sequence induction

Sponsors & Collaborators

• Ain Shams University: lead

Related 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 Officials

• Sabah Ayoub, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabah Ayoub, MD

CONTACT

966563887242; sabah_nageeb@med.asu.edu.eg

Rabah Alharbi, Saudi board

CONTACT

9660555595373; rabahsa@moh.gov.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Model Details: Randomized prospective study

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 27, 2023
• Study Start: March 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02