Head and Neck NeoplasmNCT03757091
Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery
A study testing Laryngoscopy and Tracheal Intubation in people with Head and Neck Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasm
- What is being tested?
- Laryngoscopy and Tracheal Intubation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Surgical procedures such as Tracheostomy, Laryngectomy, Esophagectomy
- Patient refusal or inability to consent for study participation
- American Society of Anesthesiology (ASA) V
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
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).
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Head and Neck Neoplasm
- Being tested
- Laryngoscopy, Tracheal Intubation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaryngoscopyDevice
Undergo video laryngoscopy
Tracheal IntubationProcedure or surgery
Undergo flexible scope intubation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Tracheal Intubation |
| 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. Receives: Device: Laryngoscopy; Procedure: Tracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intubation time, up to 3 minutes
Secondary outcomes (4)
Intubation Time
Time from induction to successful intubation
Measured: time captured when FIS passed the lips to CO2 confirmation
Number of Intubation Attempts
Number of Intubation Attempts
Measured: intubation time, up to 3 minutes
Rate of Failure at Intubation
Failed Airway Rate
Measured: 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)
Measured: duration of intubation attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start15 Jan 2019
- Primary completion30 Nov 2024
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carin Hagberg, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757091
- Sponsor's protocol ID
- 2018-0661
- Other IDs
- NCI-2018-02698, 2018-0661
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2018
- Last updated
- 18 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Scope Intubation vs.Flexible Scope Intubation and Video Laryngoscopy Combination: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03757091
- Acronym / sponsor ID
- 2018-0661
- Conditions
- Head and Neck Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (flexible intubation scope) | Active comparator | Procedure: Tracheal IntubationPatients 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) | Experimental | Device: Laryngoscopy, Procedure: Tracheal IntubationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Active bleeding from nasopharynx or oropharynx
- Trismus
- Oral pathology obstructing the glottic view
- Planned awake or nasal intubation
- Neuromuscular Blockade (NMB) contraindicated post-induction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaryngoscopyUndergo video laryngoscopy | Device | Arm B (flexible intubation scope,video laryngoscope) |
| Tracheal IntubationUndergo flexible scope intubation | Procedure or surgery | Arm A (flexible intubation scope), Arm B (flexible intubation scope,video laryngoscope) |
Primary outcome
Difficult Endotracheal Tube (ETT) Placement
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.
4 secondary outcomes
Intubation Time
Time frame: time captured when FIS passed the lips to CO2 confirmation
Number of Intubation Attempts
Time frame: intubation time, up to 3 minutes
Rate of Failure at Intubation
Time frame: during intubation process/attempt
Ease of Intubation (Provider Assessment)
Time frame: duration of intubation attempt
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Head and Neck Neoplasm
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carin Hagberg principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscopy and Tracheal Intubation in people with Head and Neck Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficult Endotracheal Tube (ETT) Placement (time frame: intubation time, up to 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.