Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
Primary Purpose
Head and Neck Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laryngoscopy
Tracheal Intubation
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Neoplasm
Eligibility Criteria
Inclusion Criteria:
- All head and neck elective 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, body mass index (BMI) · 35 kg/m^2, 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
- Pregnant females
- American Society of Anesthesiology (ASA) V
- Patient refusal or inability to consent for study participation
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A (flexible intubation scope)
Arm B (flexible intubation scope,video laryngoscope)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Rates of difficult endotracheal tube (ETT) placement
Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson.
Secondary Outcome Measures
Total time for securing the airway
Number of attempts required for intubation
Rate of failure at intubation
Incidence of desaturation
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.
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.
Full Information
NCT ID
NCT03757091
First Posted
November 26, 2018
Last Updated
October 18, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03757091
Brief Title
Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
Official Title
Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A (flexible intubation scope)
Arm Type
Active Comparator
Arm Description
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 Title
Arm B (flexible intubation scope,video laryngoscope)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laryngoscopy
Intervention Description
Undergo video laryngoscopy
Intervention Type
Procedure
Intervention Name(s)
Tracheal Intubation
Intervention Description
Undergo flexible scope intubation
Primary Outcome Measure Information:
Title
Rates of difficult endotracheal tube (ETT) placement
Description
Estimated rates of difficult ETT will be provided using exact 95% confidence interval (CI) using the method of Clopper-Pearson.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Total time for securing the airway
Time Frame
1 day
Title
Number of attempts required for intubation
Time Frame
1 day
Title
Rate of failure at intubation
Time Frame
1 day
Title
Incidence of desaturation
Time Frame
1 day
Title
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.
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carin Hagberg
Phone
713-563-0223
Email
chagberg@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carin Hagberg
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carin A. Hagberg
Phone
713-563-0223
First Name & Middle Initial & Last Name & Degree
Carin A. Hagberg
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
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