Clinical trial NCT03757091: Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
Official title: Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-11-28
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rates of difficult endotracheal tube (ETT) placement
timeFrame: 1 day
Secondary outcomes:
measure: Total time for securing the airway
timeFrame: 1 day
measure: Number of attempts required for intubation
timeFrame: 1 day
measure: Rate of failure at intubation
timeFrame: 1 day
measure: Incidence of desaturation
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carin Hagberg
role: PRINCIPAL_INVESTIGATOR
References: