Using flexible intubation scope with or without video assistance for airway management in head and neck cancer patients
Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
NA · M.D. Anderson Cancer Center · NCT03757091
This study is testing whether using a flexible intubation scope alone or with video assistance makes it easier and safer to place a breathing tube in patients with head and neck cancer before surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03757091 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a flexible intubation scope, with and without the aid of a video laryngoscope, in facilitating endotracheal tube placement for patients with head and neck cancer prior to surgery. The study aims to compare the rates of difficult intubation and the ease of using these devices, as well as to assess various outcomes such as time taken for intubation and incidence of complications. Patients will be randomized into two groups: one using only the flexible scope and the other using both the flexible scope and video laryngoscopy. The goal is to improve airway management and reduce complications during anesthesia.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with known or suspected difficult airways due to head and neck cancer or related factors.
Not a fit: Patients with active bleeding, trismus, or those requiring emergency intubation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the safety and effectiveness of intubation in patients with challenging airways, potentially reducing complications.
How similar studies have performed: Previous studies have shown promising results with similar airway management techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages ≥ 18 years of age * All surgical patients with known or suspected difficult airways that meet at least three (3) of the Difficult Airway criteria \[Mallampati III-IV, Neck circumference \> 40 cm, Sternomental distance \< 12 cm, Thyromental distance \< 6 cm, Mouth opening \< 4 cm, BMI ≥ 35 kg/m2, Upper Lip Bite Test - ULBT (class III)\] or history of radiation to the head and neck area or oral pathology obstructing the glottic view * American Society of Anesthesiology (ASA) I-IV * Has provided written informed consent Exclusion Criteria: * Active bleeding from nasopharynx or oropharynx * Trismus * Oral pathology obstructing the glottic view * Planned awake or nasal intubation * Neuromuscular Blockade (NMB) contraindicated post-induction * Emergency endotracheal intubation and patients intubated pre and post-surgery * Surgical procedures such as Tracheostomy, Laryngectomy, Esophagectomy * Patient refusal or inability to consent for study participation * American Society of Anesthesiology (ASA) V * Pregnant females
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Carin Hagberg — M.D. Anderson Cancer Center
- Study coordinator: Carin Hagberg
- Email: chagberg@mdanderson.org
- Phone: 713-563-0223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Neoplasm