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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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
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 moreTrial 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
13,667 Previous Clinical Trials
40,926,012 Total Patients Enrolled
315 Trials studying Head and Neck Neoplasms
46,181 Patients Enrolled for Head and Neck Neoplasms
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,276 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my throat or esophagus.I cannot receive muscle relaxants after anesthesia induction.I have difficulty opening my mouth.I have a challenging airway based on specific measurements or past head/neck treatments.I am 18 years old or older.I have a mouth condition that makes it hard to see my vocal cords.I have been intubated due to an emergency or around the time of surgery.I am currently experiencing bleeding from my nose or throat.I am unable or unwilling to give consent for this study.My surgery will involve being awake or having a tube placed through my nose.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (flexible intubation scope)
- Group 2: Arm B (flexible intubation scope,video laryngoscope)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment open at the moment?
"Clinicaltrials.gov displays that, as of July 6th 2022, this medical study is still actively recruiting participants; the trial was first listed on January 15th 2019."
Answered by AI
How many individuals have registered for this clinical experiment?
"Affirmative. Clinicaltrials.gov has documentation of this investigation, which was first advertised on the 15th of January 2019 and recently updated on 6 July 2022, actively recruiting 120 participants from a single site."
Answered by AI
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