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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Difficult Intubation

Intervention / Treatment
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* Device: Gliderite® shape modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stylet shape modification group<br>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<br>* 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.<br>* Other names: Lubrication of the disposable blade by a jelly substance;|
| No Intervention: Standard shape of the stylet group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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difficult intubation, blade lubrication, stylet shape