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Intubation Techniques for Head and Neck Cancer

N/A
Recruiting
Led By Carin Hagberg
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages ≥ 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial studies the use of two devices to help place a breathing tube in patients with head and neck cancer before surgery.

Who is the study for?
This trial is for adults over 18 with head and neck cancer who may have a difficult airway, as indicated by specific physical measurements or previous radiation treatment. They must be classified ASA I-IV and able to consent. Excluded are those with certain oral pathologies, trismus, need for awake/nasal intubation, contraindications to muscle relaxants post-induction, emergency intubation needs, specific surgeries like Tracheostomy or Laryngectomy, inability to consent, ASA V classification or active nasopharynx/oropharynx bleeding.Check my eligibility
What is being tested?
The study is testing the effectiveness of using a flexible intubation scope alone versus combined with a video laryngoscope in placing an endotracheal tube before surgery in patients with head and neck cancer. These devices display the airway on screen potentially reducing complications during tube placement such as pain or mouth injury.See study design
What are the potential side effects?
Potential side effects from using these devices might include discomfort in the throat or mouth area, minor injuries inside the mouth or throat such as cuts or bruises due to tube placement process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rates of difficult endotracheal tube (ETT) placement
Secondary outcome measures
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.
Incidence of desaturation
Number of attempts required for intubation
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (flexible intubation scope,video laryngoscope)Experimental Treatment2 Interventions
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.
Group II: Arm A (flexible intubation scope)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tracheal Intubation
2021
N/A
~430
Laryngoscopy
2019
N/A
~480

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,964,934 Total Patients Enrolled
314 Trials studying Head and Neck Neoplasms
45,860 Patients Enrolled for Head and Neck Neoplasms
M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,535 Total Patients Enrolled
64 Trials studying Head and Neck Neoplasms
20,415 Patients Enrolled for Head and Neck Neoplasms
Carin HagbergPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Tracheal Intubation Clinical Trial Eligibility Overview. Trial Name: NCT03757091 — N/A
Head and Neck Neoplasms Research Study Groups: Arm A (flexible intubation scope), Arm B (flexible intubation scope,video laryngoscope)
Head and Neck Neoplasms Clinical Trial 2023: Tracheal Intubation Highlights & Side Effects. Trial Name: NCT03757091 — N/A
Tracheal Intubation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03757091 — N/A
~10 spots leftby Dec 2024
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