Clinical trial NCT05744388: Modification of the Stylet Shape of the Glidescope for Facilitating Difficult Intubation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult Intubation
Keywords: difficult intubation
blade lubrication
stylet shape
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Intubation time in seconds
timeFrame: intraoperative time
Secondary outcomes:
measure: Number of trials of endotracheal intubation
timeFrame: intraoperative time
measure: mucosal damage during the intubation
timeFrame: intraoperative time
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Sabah Ayoub, MD
role: PRINCIPAL_INVESTIGATOR
References: