M D Anderson Cancer Center
Houston, Texas, 77030, United States
NCT Number: NCT03757091
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo video laryngoscopy
Undergo flexible scope intubation
Time frame: 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.
Time frame: time captured when FIS passed the lips to CO2 confirmation
Time from induction to successful intubation
Time frame: intubation time, up to 3 minutes
Number of Intubation Attempts
Time frame: during intubation process/attempt
Failed Airway Rate
Time frame: 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)
M.D. Anderson Cancer Center
Other
Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04477759
Head and Neck Neoplasm, Head and Neck Neoplasms
Milwaukee, Wisconsin, United States
View Trial DetailsNCT03012581
Adenocarcinoma, Cancer With POLE Exonucleasic Domain Mutation
Villejuif, France
View Trial DetailsNCT03418480
Cervical Neoplasm, Female Urogenital Diseases
Southampton, Hampshire, United Kingdom
View Trial DetailsNCT02960308
Head and Neck Neoplasm, Head and Neck Neoplasms
Los Angeles, California, United States
View Trial Details