Intubation Techniques for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Carin A. Hagberg

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active bleeding, Trismus, Pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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).

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

Research Team

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.

I am 18 years old or older.

Exclusion Criteria

I have had surgery on my throat or esophagus.

I cannot receive muscle relaxants after anesthesia induction.

Pregnant females

Trial 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 (Procedure)
• Tracheal Intubation (Procedure)

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

Group I: Arm B (flexible intubation scope,video laryngoscope) Experimental Treatment 2 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 Control 1 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic management of the patient scheduled for head and neck cancer surgery. Dougherty, TB., Nguyen, DT.[2019]

In a survey of 342 French Emergency Departments, only 56% had access to videolaryngoscopy for emergency intubation, and the majority (82%) primarily used direct laryngoscopy without a stylet, indicating a potential gap in the adoption of newer, safer intubation techniques.

Despite the limited use of videolaryngoscopy, 74% of the EDs had established intubation protocols, and 92% provided capnography for verifying tube placement, suggesting a commitment to safety in intubation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training approaches and devices utilization during endotracheal intubation in French Emergency Departments: a nationwide survey. Le Borgne, P., Alamé, K., Chenou, A., et al.[2023]

A review of 7827 safety reports from 2015 to 2020 revealed that only 67 (0.85%) were related to perioperative airway management, indicating that while these incidents are relatively rare, they can still pose significant risks to patients.

The most common adverse event was 'Intubation Injury,' accounting for 35.8% of airway management incidents, with the majority of events causing temporary or minor harm, highlighting the need for improved training and resources to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. Osgood, KB., Krishnan, S., Wheeler, KK., et al.[2022]

Video-assisted intubating stylet technique was successfully used in five patients with difficult airways, suggesting it is a feasible and safe method for anesthetized tracheal intubation.

This technique may offer advantages over traditional methods by improving laryngeal visibility and increasing the likelihood of successful intubation in patients with challenging airway conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-Assisted Intubating Stylet Technique for Difficult Intubation: A Case Series Report. Tsay, PJ., Yang, CP., Luk, HN., et al.[2022]

Preoperative airway assessment is crucial for ensuring safe anesthesia during head and neck surgeries, as it helps determine the best method for tracheal intubation.

For laser surgeries and other specialized procedures, careful selection of endotracheal tubes and preparation of emergency airway devices are essential to manage potential complications effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risk management of anesthesia for head and neck surgery]. Makita, K.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Update on Tracheostomy and Upper Airway Considerations in the Head and Neck Cancer Patient. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Anesthetic management of the patient scheduled for head and neck cancer surgery. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Training approaches and devices utilization during endotracheal intubation in French Emergency Departments: a nationwide survey. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Anesthetic management of the patient undergoing head and neck cancer surgery. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Video-Assisted Intubating Stylet Technique for Difficult Intubation: A Case Series Report. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Risk management of anesthesia for head and neck surgery]. [2022]