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

Head and Neck Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03757091
• Other study ID #: 2018-0661
• Secondary ID: NCI-2018-0269820
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Carin Hagberg
• Phone: 713-563-0223
• Email: chagberg[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasm
• Head and Neck Neoplasms

Intervention

Device:
• Laryngoscopy
Undergo video laryngoscopy

Procedure:
• Tracheal Intubation
Undergo flexible scope intubation

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of difficult endotracheal tube (ETT) placement	Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson.	1 day
Secondary	Total time for securing the airway		1 day
Secondary	Number of attempts required for intubation		1 day
Secondary	Rate of failure at intubation		1 day
Secondary	Incidence of desaturation		1 day
Secondary	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.	For complications, researchers will assign a '0' for no complication arising and a '1' for any complications arising. The total score will range from 0 to 3 and will be summarized using frequencies and percentages related to each level of the total score and using the mean score and standard deviation, whichever is more appropriate.	1 day

External Links

•   MD Anderson Cancer Center Website