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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Carin Hagberg
chagberg@mdanderson.org
713-563-0223
Time Frame
Start Date: 2019-01-15
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 144
Treatments
Active_comparator: Arm A (flexible intubation scope)
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.
Experimental: Arm B (flexible intubation scope,video laryngoscope)
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov