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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02698 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0661 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
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| National Cancer Institute (NCI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (flexible intubation scope) | Active Comparator | 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. |
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| Arm B (flexible intubation scope,video laryngoscope) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngoscopy | Device | Undergo video laryngoscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Difficult Endotracheal Tube (ETT) Placement | 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. | intubation time, up to 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | Time from induction to successful intubation | time captured when FIS passed the lips to CO2 confirmation |
| Number of Intubation Attempts | Number of Intubation Attempts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin Hagberg | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flexible Intubation Scope (FIS) | control group will utilize FIS (flexible intubation scope) |
| FG001 | Flexible Intubation Scope + Video Laryngoscope (FIS+VL) | treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2024 |
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| Tracheal Intubation |
| Procedure |
Undergo flexible scope intubation |
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| intubation time, up to 3 minutes |
| Rate of Failure at Intubation | Failed Airway Rate | during intubation process/attempt |
| Ease of Intubation (Provider Assessment) | The number of people who had 1= extremely easy, 2=somewhat easy, 3=resistance, 4= difficult, 5= unsuccessful (for both groups) | duration of intubation attempt |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Flexible Intubation Scope (FIS) | control group will utilize FIS (flexible intubation scope) |
| BG001 | Flexible Intubation Scope + Video Laryngoscope (FIS+VL) | treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Difficult Endotracheal Tube (ETT) Placement | 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. | Posted | Count of Participants | Participants | intubation time, up to 3 minutes |
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| Secondary | Intubation Time | Time from induction to successful intubation | Posted | Mean | 95% Confidence Interval | seconds | time captured when FIS passed the lips to CO2 confirmation |
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| Secondary | Number of Intubation Attempts | Number of Intubation Attempts | Posted | Count of Participants | Participants | intubation time, up to 3 minutes |
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| Secondary | Rate of Failure at Intubation | Failed Airway Rate | Posted | Number | 95% Confidence Interval | percentage of participants | during intubation process/attempt |
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| Secondary | Ease of Intubation (Provider Assessment) | The number of people who had 1= extremely easy, 2=somewhat easy, 3=resistance, 4= difficult, 5= unsuccessful (for both groups) | Posted | Count of Participants | Participants | duration of intubation attempt |
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From induction to one hour after PACU arrival, up to 6 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flexible Intubation Scope (FIS) | control group will utilize FIS (flexible intubation scope) | 0 | 69 | 0 | 69 | 0 | 69 |
| EG001 | Flexible Intubation Scope + Video Laryngoscope (FIS+VL) | treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope) | 0 | 66 | 0 | 66 | 0 | 66 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carin Hagberg | The University of Texas MD Anderson Cancer Center | (713) 745-4495 | chagberg@mdanderson.org |
| Sep 22, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
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| D006258 | Head and Neck Neoplasms |
| ID | Term |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
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| D007828 | Laryngoscopy |
| D007442 | Intubation, Intratracheal |
| ID | Term |
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| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| Between 18 and 65 years |
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| >=65 years |
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