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

NCT ID: NCT05744388

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-07-01

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.

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.

Conditions

Difficult Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Gliderite® shape modification

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Lubrication of the disposable blade by a jelly substance

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sabah Nageeb

Lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabah Ayoub, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Central Contacts

Sabah Ayoub, MD

Role: CONTACT

sabah_nageeb@med.asu.edu.eg

966563887242 ext. 563887242

Rabah Alharbi, Saudi board

Role: CONTACT

rabahsa@moh.gov.sa

9660555595373 ext. 0555595373

Related Links

https://doi.org/10.1038/s41598-021-00115-x

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

Other Identifiers

Glidescope

Identifier Type: -

Identifier Source: org_study_id