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

NCT03757091 | Completed Results FDA Device

• 2 other identifiers: 2018-0661NCI-2018-02698
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Head and Neck Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intubation Time

  time captured when FIS passed the lips to CO2 confirmation

• Number of Intubation Attempts

  intubation time, up to 3 minutes

• Rate of Failure at Intubation

  during intubation process/attempt

• Ease of Intubation (Provider Assessment)

  duration of intubation attempt

Study Arms (2)

Arm A (flexible intubation scope)

ACTIVE COMPARATOR

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

Arm B (flexible intubation scope,video laryngoscope)

EXPERIMENTAL

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; Procedure: Tracheal Intubation

Interventions

Laryngoscopy DEVICE

Undergo video laryngoscopy

Arm B (flexible intubation scope,video laryngoscope)

Tracheal Intubation PROCEDURE

Undergo flexible scope intubation

Arm A (flexible intubation scope); Arm B (flexible intubation scope,video laryngoscope)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Laryngoscopy; Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Airway Management; Therapeutics; Intubation; Investigative Techniques

Results Point of Contact

• Title: Dr. Carin Hagberg
• Organization: The University of Texas MD Anderson Cancer Center

chagberg@mdanderson.org

(713) 745-4495

Study Officials

• Carin Hagberg

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: January 15, 2019
• Primary Completion: November 30, 2024
• Study Completion: February 2, 2026
• Last Updated: February 18, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-02

Locations

US (1)