Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
- Conditions
- Head and Neck Neoplasm
- Interventions
- Procedure: Tracheal IntubationDevice: Laryngoscopy
- Registration Number
- NCT03757091
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A (flexible intubation scope) Tracheal Intubation 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 (flexible intubation scope,video laryngoscope) Laryngoscopy 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. Arm B (flexible intubation scope,video laryngoscope) Tracheal Intubation 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.
- Primary Outcome Measures
Name Time Method Rates of difficult endotracheal tube (ETT) placement 1 day Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson.
- Secondary Outcome Measures
Name Time Method Total time for securing the airway 1 day Complications 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. 1 day For complications, researchers will assign a '0' for no complication arising and a '1' for any complications arising. The total score will range from 0 to 3 and will be summarized using frequencies and percentages related to each level of the total score and using the mean score and standard deviation, whichever is more appropriate.
Incidence of desaturation 1 day Rate of failure at intubation 1 day Number of attempts required for intubation 1 day
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States