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Completed

NCT Number: NCT03757091

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngoscopy

Device

Undergo video laryngoscopy

tracheal intubation

Procedure

Undergo flexible scope intubation

Primary outcomes

  1. Difficult Endotracheal Tube (ETT) Placement

    Time frame: intubation time, up to 3 minutes

    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.

Secondary outcomes

  1. Intubation Time

    Time frame: time captured when FIS passed the lips to CO2 confirmation

    Time from induction to successful intubation

  2. Number of Intubation Attempts

    Time frame: intubation time, up to 3 minutes

    Number of Intubation Attempts

  3. Rate of Failure at Intubation

    Time frame: during intubation process/attempt

    Failed Airway Rate

  4. Ease of Intubation (Provider Assessment)

    Time frame: duration of intubation attempt

    The number of people who had 1= extremely easy, 2=somewhat easy, 3=resistance, 4= difficult, 5= unsuccessful (for both groups)

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Nov 28, 2018
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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