Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery

Study Overview
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Brief Summary
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This trial studies how well flexible intubation scope with or without video laryngoscope works in supporting endotracheal tube placement in patients with head and neck cancer before surgery. Flexible intubation scope and video laryngoscope are devices that have a small camera to help the doctor see the patient's airway on a screen. Both devices may help the doctor who gives anesthesia prevent complications from placing the breathing tube (such as pain or mouth injury).

Detailed Description
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PRIMARY OBJECTIVES: I. To compare the rates of difficult endotracheal tube (ETT) placement using a flexible intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in difficult airway management. SECONDARY OBJECTIVES: I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of the video laryngoscope (VL). II. Total time for securing the airway. III. Number of attempts required for intubation. IV. Rate of failure at intubation. V. Incidence of desaturation. VI. Assessment for hoarseness, sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury, tongue injury, or tooth damage. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device. ARM B: Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device.

Official Title
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Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial

Conditions
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Head and Neck Neoplasm

Intervention / Treatment
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* Device: Laryngoscopy
* Procedure: Tracheal Intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages ≥ 18 years of age All surgical patients with known or suspected difficult airways that meet at least three (3) of the Difficult Airway criteria [Mallampati III-IV, Neck circumference > 40 cm, Sternomental distance < 12 cm, Thyromental distance < 6 cm, Mouth opening < 4 cm, BMI ≥ 35 kg/m2, Upper Lip Bite Test - ULBT (class III)] or history of radiation to the head and neck area or oral pathology obstructing the glottic view American Society of Anesthesiology (ASA) I-IV Has provided written informed consent Exclusion Criteria: Active bleeding from nasopharynx or oropharynx Trismus Oral pathology obstructing the glottic view Planned awake or nasal intubation Neuromuscular Blockade (NMB) contraindicated post-induction Emergency endotracheal intubation and patients intubated pre and post-surgery Surgical procedures such as Tracheostomy, Laryngectomy, Esophagectomy Patient refusal or inability to consent for study participation American Society of Anesthesiology (ASA) V Pregnant females

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A (flexible intubation scope)<br>Patients undergo flexible scope intubation up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device. | Procedure: Tracheal Intubation<br>* Undergo flexible scope intubation<br>|
| Experimental: Arm B (flexible intubation scope,video laryngoscope)<br>Patients undergo flexible scope intubation and video laryngoscopy up to 2 attempts following induction of general anesthesia and adequate manual ventilation. In case of failed 2 attempts, patients undergo a third attempt utilizing another technique or device. | Device: Laryngoscopy<br>* Undergo video laryngoscopy<br>Procedure: Tracheal Intubation<br>* Undergo flexible scope intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of difficult endotracheal tube (ETT) placement | Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time for securing the airway |  | 1 day | 
| Number of attempts required for intubation |  | 1 day | 
| Rate of failure at intubation |  | 1 day | 
| Incidence of desaturation |  | 1 day | 
| Complications of difficult Endotracheal Tube (ETT) placement using a flexible intubation scope (FIS) versus a combination of flexible intubation and video laryngoscopy in difficult airway management. | For complications, researchers will assign a '0' for no complication arising and a '1' for any complications arising. The total score will range from 0 to 3 and will be summarized using frequencies and percentages related to each level of the total score and using the mean score and standard deviation, whichever is more appropriate. | 1 day |