NCT03757091

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Head and Neck Neoplasm

Interventions

Type	Name	Description
DEVICE	Laryngoscopy	Undergo video laryngoscopy
PROCEDURE	Tracheal Intubation	Undergo flexible scope intubation

Timeline

• Start date: 2019-01-15
• Primary completion: 2024-11-30
• Completion: 2026-02-02
• First posted: 2018-11-28
• Last updated: 2026-02-18
• Results posted: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study