Status:
RECRUITING
Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03757091
Start Date
January 15 2019
End Date
August 31 2025
Last Update
April 1 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030