Houston, Texas 77030


Purpose:

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 summary:

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.


Criteria:

Inclusion Criteria: - All head and neck elective 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, body mass index (BMI) · 35 kg/m^2, 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 - Pregnant females - American Society of Anesthesiology (ASA) V - Patient refusal or inability to consent for study participation


NCT ID:

NCT03757091


Primary Contact:

Principal Investigator
Carin Hagberg
M.D. Anderson Cancer Center

Carin Hagberg
Phone: 713-563-0223
Email: chagberg@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Carin A. Hagberg
Phone: 713-563-0223

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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