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

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).

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasm
• Intervention / Treatment: Procedure: Tracheal Intubation; Device: Laryngoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A (flexible intubation scope); 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; Undergo flexible scope intubation
Experimental: Arm B (flexible intubation scope,video laryngoscope); 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.	Procedure: Tracheal Intubation; Undergo flexible scope intubation; Device: Laryngoscopy; Undergo video laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficult Endotracheal Tube (ETT) Placement	Defined as the number of participants with any of the following during initial intubation attempt.1 Intubation time exceeding 60 seconds, 2. Failure to intubate on the first attempt, 3. Provider assessment of intubation as difficult or unsuccessful.	intubation time, up to 3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation Time	Time from induction to successful intubation	time captured when FIS passed the lips to CO2 confirmation
Number of Intubation Attempts	Number of Intubation Attempts	intubation time, up to 3 minutes
Rate of Failure at Intubation	Failed Airway Rate	during intubation process/attempt
Ease of Intubation (Provider Assessment)	The number of people who had 1= extremely easy, 2=somewhat easy, 3=resistance, 4= difficult, 5= unsuccessful (for both groups)	duration of intubation attempt

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Carin Hagberg, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): February 2, 2026

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Investigative Techniques; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Diagnostic Techniques, Respiratory System; Airway Management; Intubation; Otorhinolaryngologic Surgical Procedures; Intubation, Intratracheal; Laryngoscopy
• Other Study ID Numbers: 2018-0661 (Other Identifier: M D Anderson Cancer Center); NCI-2018-02698 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No