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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

Must not have

Surgical procedures such as Tracheostomy, Laryngectomy, Esophagectomy

Neuromuscular Blockade (NMB) contraindicated post-induction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my throat or esophagus.

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I cannot receive muscle relaxants after anesthesia induction.

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I have difficulty opening my mouth.

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I have a mouth condition that makes it hard to see my vocal cords.

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I have been intubated due to an emergency or around the time of surgery.

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I am currently experiencing bleeding from my nose or throat.

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I am unable or unwilling to give consent for this study.

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My surgery will involve being awake or having a tube placed through my nose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rates of difficult endotracheal tube (ETT) placement

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Laryngoscopy

2019

N/A

~480

Tracheal Intubation

2021

N/A

~430