Head and Neck Neoplasm
Conditions
Brief summary
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).
Detailed description
PRIMARY OBJECTIVES: I. To compare the rates 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. SECONDARY OBJECTIVES: I. To compare the ease of using a flexible intubation scope (FIS) with and without the use of the video laryngoscope (VL). II. Total time for securing the airway. III. Number of attempts required for intubation. IV. Rate of failure at intubation. V. Incidence of desaturation. VI. Assessment for hoarseness, sore mouth, neck, or jaw, dysphonia, dysphagia, lip injury, tongue injury, or tooth damage. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: 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. ARM B: 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.
Interventions
DEVICELaryngoscopy
Undergo video laryngoscopy
PROCEDURETracheal Intubation
Undergo flexible scope intubation
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difficult Endotracheal Tube (ETT) Placement | intubation time, up to 3 minutes | Defined as the number of participants with any of the following during initial intubation attempt.1 Intubation time exceeding 60 seconds, 2. Failure to intubate on the first attempt, 3. Provider assessment of intubation as difficult or unsuccessful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time | time captured when FIS passed the lips to CO2 confirmation | Time from induction to successful intubation |
| Number of Intubation Attempts | intubation time, up to 3 minutes | Number of Intubation Attempts |
| Rate of Failure at Intubation | during intubation process/attempt | Failed Airway Rate |
| Ease of Intubation (Provider Assessment) | duration of intubation attempt | The number of people who had 1= extremely easy, 2=somewhat easy, 3=resistance, 4= difficult, 5= unsuccessful (for both groups) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarin Hagberg
M.D. Anderson Cancer Center
Participant flow
Recruitment details
The Main OR procedure daily schedule will be used for patient selection. Once eligibility of a study candidate has been identified, the study coordinator will be informed to start the patient interview and obtain written informed consent.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants |
| Age, Continuous | 59.26 years STANDARD_DEVIATION 13.97 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 135 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 66 |
| other Total, other adverse events | 0 / 69 | 0 / 66 |
| serious Total, serious adverse events | 0 / 69 | 0 / 66 |
Outcome results
None listed