144 Participants Needed

Intubation Techniques for Head and Neck Cancer

CH
Overseen ByCarin Hagberg
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is intubation generally safe for head and neck cancer patients?

Intubation, including techniques like videolaryngoscopy, is generally safe but can have risks such as temporary or minor harm, especially in complex cases like head and neck cancer. Safety measures and proper training can help reduce these risks.12345

How does the treatment Tracheal Intubation differ from other treatments for head and neck cancer?

Tracheal intubation is a unique treatment for head and neck cancer patients because it focuses on securing the airway, which is often complicated by tumors in this region. Unlike other treatments that target the cancer itself, intubation is crucial for safely managing the airway during surgery, especially in patients with difficult airways due to tumor obstruction.23678

What is the purpose of this trial?

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).

Research Team

CH

Carin A. Hagberg

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

American Society of Anesthesiology (ASA) I-IV
I have a challenging airway based on specific measurements or past head/neck treatments.
Has provided written informed consent

Exclusion Criteria

I have had surgery on my throat or esophagus.
I cannot receive muscle relaxants after anesthesia induction.
Pregnant females
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients undergo flexible scope intubation with or without video laryngoscopy following induction of general anesthesia and adequate manual ventilation.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for complications such as hoarseness, sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury, tongue injury, or tooth damage.

1 day

Treatment Details

Interventions

  • Laryngoscopy
  • Tracheal Intubation
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 2916 critically ill patients, videolaryngoscopy led to a higher first-pass intubation success rate (84%) compared to direct laryngoscopy (79%), indicating it may be a more effective method for intubation in this high-risk population.
Despite being used in patients with a higher likelihood of difficult airways, videolaryngoscopy did not increase the risk of major adverse events, suggesting it is a safe option for intubation.
Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study.Russotto, V., Lascarrou, JB., Tassistro, E., et al.[2023]
Patients with head and neck cancer are at a higher risk for airway complications during surgery, necessitating careful management strategies.
The article discusses updated techniques for handling difficult airways in these patients, including improved methods for intubation, extubation, and tracheostomy management, which are crucial for ensuring patient safety during surgical procedures.
Update on Tracheostomy and Upper Airway Considerations in the Head and Neck Cancer Patient.Wandell, GM., Merati, AL., Meyer, TK.[2022]
Careful airway assessment is crucial for patients undergoing head and neck cancer surgery, as it helps determine the safest method for securing the airway, which may include awake intubation or tracheostomy if necessary.
Post-operative extubation can be more challenging than intubation, highlighting the need for meticulous anesthetic management to prevent airway complications during and after surgery.
Anesthetic management of the patient scheduled for head and neck cancer surgery.Dougherty, TB., Nguyen, DT.[2019]

References

Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. [2023]
Update on Tracheostomy and Upper Airway Considerations in the Head and Neck Cancer Patient. [2022]
Anesthetic management of the patient scheduled for head and neck cancer surgery. [2019]
Training approaches and devices utilization during endotracheal intubation in French Emergency Departments: a nationwide survey. [2023]
Airway management in the operating room setting: An analysis of reported safety events. [2022]
Anesthetic management of the patient undergoing head and neck cancer surgery. [2019]
Video-Assisted Intubating Stylet Technique for Difficult Intubation: A Case Series Report. [2022]
[Risk management of anesthesia for head and neck surgery]. [2022]
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