Intubation Techniques for Head and Neck Cancer

Overseen By Carin Hagberg

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active bleeding, Trismus, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better methods for placing breathing tubes in patients with head and neck cancer before surgery. It compares two devices: a flexible intubation scope, a tube with a camera, and a video laryngoscope, which uses a camera to display the airway on a screen. The goal is to determine which method better prevents complications, such as pain or mouth injuries. Patients diagnosed with head and neck cancer who have undergone treatments or have conditions that complicate airway management, like a history of radiation in that area, may be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to improving surgical outcomes and airway management techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that these intubation techniques are safe for patients with head and neck cancer?

Research shows that both flexible intubation scopes and video laryngoscopes are generally safe tools for assisting doctors in placing breathing tubes during surgery. Studies have found that using a flexible intubation scope can sometimes lead to changes in the anesthesia plan, potentially improving safety. Specifically, one study found that reviewing the scope led to changes in about 32% of cases.

For video laryngoscopy, various studies have examined its use in patients with head and neck issues. The findings suggest that this tool is effective and well-tolerated. One study reviewed video laryngoscopy over ten years and found it to be a safe option compared to traditional methods.

Overall, these devices enhance doctors' ability to see the airway, making the intubation process safer and reducing complications like pain or mouth injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative intubation techniques for head and neck cancer patients. Unlike traditional intubation methods, which often rely solely on direct laryngoscopy, this trial examines the use of a flexible intubation scope and video laryngoscopy. These methods aim to improve the success rate of intubation attempts and enhance patient safety by providing better visualization of the airway, potentially reducing complications. By comparing these advanced techniques, the trial aims to determine the most effective approach, which could lead to improved outcomes during surgeries requiring general anesthesia.

What evidence suggests that these intubation techniques are effective for head and neck cancer patients?

Research has shown that using a flexible intubation scope, particularly with a video laryngoscope, can simplify the placement of breathing tubes in patients with head and neck cancer. In this trial, participants in Arm A will undergo flexible scope intubation, while those in Arm B will experience both flexible scope intubation and video laryngoscopy. One study found that video laryngoscopy often results in successful tube placement on the first attempt. It is frequently recommended as the optimal choice for airway management in these cases. Video laryngoscopy is favored over direct laryngoscopy because it enhances visibility and reduces issues like pain or injury. The flexible intubation scope, equipped with a small camera, also aids in safer and more effective tube placement. Together, these tools help minimize the risk of complications during surgery. ^{2 3 4 6 7}

Who Is on the Research Team?

Carin A. Hagberg

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Proper assessment of the patient's upper airway is crucial for anesthesiologists to determine the safest intubation method before surgery, especially in head and neck cancer patients.

In cases of difficult airways, techniques such as flexible fiberoptic-guided intubation or initial tracheostomy may be necessary to secure the airway, ensuring patient safety during and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic management of the patient undergoing head and neck cancer surgery. Supkis, DE., Dougherty, TB., Nguyen, DT., et al.[2019]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8803369/

First-Pass Success of Tracheal Intubation With ... Videolaryngoscopy was associated with high first-attempt intubation success and we recommend its use as the initial choice for airway management in head and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S295055342400039X

Effects of head and neck radiotherapy on airway ... The primary aim of this study is to assess airway-related outcomes following HNRT treatment, while evaluating its potential as a risk factor for prediction of ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03757091/flexible-intubation-scope-with-or-without-video-laryngoscope-in-supporting-endotracheal-tube-placement-in-patients-with-head-and-neck-cancer-before-surgery

Flexible Intubation Scope With or Without Video ... This trial studies how well flexible intubation scope with or without video laryngoscope works in supporting endotracheal tube placement in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04628611

Comparison Between Rigid Video Assisted Laryngoscopy ... Comparison Between Rigid Video Assisted Laryngoscopy vs Flexible Laryngoscopy in Anticipated Difficult Intubation. ClinicalTrials.gov ID NCT04628611.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39315438/

The Impact of Preoperative Flexible Fiberoptic ... Reviewing the FFL led to changes in the anesthesia team's intubation plan in 32% of the cases in our pilot study.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/190479

Flexible Intubation Scope With or Without Video ... This trial studies how well flexible intubation scope with or without video laryngoscope works in supporting endotracheal tube placement in ...

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/01455613241275485

The Impact of Preoperative Flexible Fiberoptic ... Results: Thirty-four patients (49-87 years of age) were included in the study. Eleven intubation plans were changed after reviewing the FFL, ...