Difficult IntubationNCT03265938
Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology
An observational study of Difficult Intubation, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Indirect Laryngoscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 24 Jul 2019
- Phase
- Observational
- 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
Study population: The study population will include all patients scheduled to undergo a surgical procedure at the Mount Sinai Hospital (New York, NY)
Who may be able to join
- Age> 18 years old
- Presence of oral, pharyngeal or laryngeal mass or history of surgery or radiation for head and neck cancer
- Requiring awake flexible bronchoscopic intubation for surgery
- Willing and able to provide informed consent
Who cannot join
- Emergency Procedure
- Presence of one or more loose teeth
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Less often, airway management can be difficult and can result in patient harm. In order to reduce risk, anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and doing a physical exam, which can aid in predicting which airways may be difficult to manage. The "gold standard" for management of the anticipated difficult airway is to perform an awake flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This affords added safety because the airway remains patent and the patient breaths spontaneously until a tracheal tube is secured, at which point general anesthesia can be induced.
Recently, authors have advocated for alternative methods of management of the predicted difficult airway, most commonly by using a video laryngoscope to perform the awake intubation. A video laryngoscope provides an indirect view of the larynx using a camera at the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency compared to flexible bronchoscopy.
Previous studies that have shown successful awake intubation with video laryngoscopy in the predicted difficult airway have not included patients with head and neck pathology, including malignancies or a history of head and neck surgery or radiation. In this study, the study team will perform video laryngoscopy in patients with head and neck pathology who require awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of the larynx with video laryngoscopy in some patients with head and neck pathology. If there is a significant incidence of difficult video laryngoscopy in this patient population, it will reinforce that anesthesiologists need to continue to learn and maintain skills in bronchoscopic intubation.
- Conditions
- Difficult Intubation
- Being tested
- Indirect Laryngoscopy
- Keywords
- Head and Neck cancer, Cancer of oral cavity, Ear, Nose and Throat, Indirect laryngoscopy, Awake intubation, Expected difficult intubation
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect LaryngoscopyDevice
Also called Glidescope AVL Indirect Laryngoscopy, C-MAC D-Blade Indirect Laryngoscopy
The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Indirect laryngoscopy | Head and neck pathology patients undergoing indirect laryngoscopy. Patients with a past medical history of active or previously treated head and neck pathology. Receives: Device: Indirect Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade
Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC
Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
Measured: Day 1
Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL
Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL
Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
Measured: Day 1
Secondary outcomes (6)
Cormack-Lehane Grade Obtained With CMAC D Blade
Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
Measured: Day 1
Cormack-Lehane Grade Obtained With Glidescope AVL
Cormack-Lehane grade in patients with head and neck pathology of the larynx.
Cormack-Lehane grade:
Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
Measured: Day 1
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.
Measured: Day 1
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with head and neck masses.
Measured: Day 1
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
Measured: Day 1
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
Cormack-Lehane view obtained by video laryngoscopy after awake flexible bronchoscopic intubation in patients with a history of neck radiation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start13 Sep 2017
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
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.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime B Hyman, Icahn School of Medicine at Mount Sinai
- Investigators
- Jaime Hyman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265938
- Sponsor's protocol ID
- GCO 17-0963
- Status last verified
- Jun 2020
- First submitted
- 25 Aug 2017
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
PubMed 23364566Ahmad I, Bailey CR. Time to abandon awake fibreoptic intubation? Anaesthesia. 2016 Jan;71(1):12-6. doi: 10.1111/anae.13333. No abstract available.
PubMed 26684527Kramer A, Muller D, Pfortner R, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC((R)) D-BLADE) nasal awake intubation under local anaesthesia. Anaesthesia. 2015 Apr;70(4):400-6. doi: 10.1111/anae.13016.
PubMed 25764403Rosenstock CV, Thogersen B, Afshari A, Christensen AL, Eriksen C, Gatke MR. Awake fiberoptic or awake video laryngoscopic tracheal intubation in patients with anticipated difficult airway management: a randomized clinical trial. Anesthesiology. 2012 Jun;116(6):1210-6. doi: 10.1097/ALN.0b013e318254d085.
PubMed 22487805Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
PubMed 21150569Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
PubMed 21447488Fiadjoe JE, Litman RS. Difficult tracheal intubation: looking to the past to determine the future. Anesthesiology. 2012 Jun;116(6):1181-2. doi: 10.1097/ALN.0b013e318254d0a0. No abstract available.
PubMed 22487804Popat MT, Srivastava M, Russell R. Awake fibreoptic intubation skills in obstetric patients: a survey of anaesthetists in the Oxford region. Int J Obstet Anesth. 2000 Apr;9(2):78-82. doi: 10.1054/ijoa.1999.0361.
PubMed 15321093
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Video Laryngoscopy in Patients With Head and Neck Pathology
- ClinicalTrials.gov ID
- NCT03265938
- Acronym / sponsor ID
- GCO 17-0963
- Conditions
- Difficult Intubation
- Keywords
- Head and Neck cancer, Cancer of oral cavity, Ear, Nose and Throat, Indirect laryngoscopy, Awake intubation, Expected difficult intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who undergo general anesthesia for surgical procedures frequently need to have a breathing tube placed ("tracheal intubation") for the duration of the procedure. Most often airway management is routine for an experienced anesthesiologist. Less often, airway management can be difficult and can result in patient harm. In order to reduce risk, anesthesiologists routinely evaluate patients' airways by obtaining a relevant history and doing a physical exam, which can aid in predicting which airways may be difficult to manage. The "gold standard" for management of the anticipated difficult airway is to perform an awake flexible bronchoscopic intubation after anesthetizing the airway with local anesthesia. This affords added safety because the airway remains patent and the patient breaths spontaneously until a tracheal tube is secured, at which point general anesthesia can be induced.
Recently, authors have advocated for alternative methods of management of the predicted difficult airway, most commonly by using a video laryngoscope to perform the awake intubation. A video laryngoscope provides an indirect view of the larynx using a camera at the tip of a rigid laryngoscope. It takes less training to gain and maintain proficiency compared to flexible bronchoscopy.
Previous studies that have shown successful awake intubation with video laryngoscopy in the predicted difficult airway have not included patients with head and neck pathology, including malignancies or a history of head and neck surgery or radiation. In this study, the study team will perform video laryngoscopy in patients with head and neck pathology who require awake bronchoscopic intubation for surgery after placement of the tracheal tube and induction of anesthesia. The study team hypothesize that it will be difficult to obtain a good view of the larynx with video laryngoscopy in some patients with head and neck pathology. If there is a significant incidence of difficult video laryngoscopy in this patient population, it will reinforce that anesthesiologists need to continue to learn and maintain skills in bronchoscopic intubation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indirect laryngoscopy | – | Device: Indirect LaryngoscopyHead and neck pathology patients undergoing indirect laryngoscopy. Patients with a past medical history of active or previously treated head and neck pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all patients scheduled to undergo a surgical procedure at the Mount Sinai Hospital (New York, NY)
Key inclusion criteria (4 listed)
- Age> 18 years old
- Presence of oral, pharyngeal or laryngeal mass or history of surgery or radiation for head and neck cancer
- Requiring awake flexible bronchoscopic intubation for surgery
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Emergency Procedure
- Presence of one or more loose teeth
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 |
|---|---|---|
| Indirect LaryngoscopyAlso: Glidescope AVL Indirect Laryngoscopy, C-MAC D-Blade Indirect LaryngoscopyThe attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope. | Device | Indirect laryngoscopy |
Primary outcome
Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade
Time frame: Day 1
Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology with CMAC Cormack-Lehane grade in patients with head and neck pathology of the larynx. Cormack-Lehane grade: Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
Number of Participants With Cormack-Lehane Grade >2 Obtained With Glidescope AVL
Time frame: Day 1
Number of participants with difficult (Cormack-Lehane grade >2) video laryngoscopic view of the larynx after awake flexible bronchoscopic intubation in patients with head and neck pathology obtained with Glidescope AVL Cormack-Lehane grade in patients with head and neck pathology of the larynx. Cormack-Lehane grade: Grade 1: full view of the glottis Grade 2a: partial view of the glottis Grade 2b: arytenoids only Grade 3: epiglottis only Grade 4: neither glottis or epiglottis identified
6 secondary outcomes
Cormack-Lehane Grade Obtained With CMAC D Blade
Time frame: Day 1
Cormack-Lehane Grade Obtained With Glidescope AVL
Time frame: Day 1
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With CMAC D Blade
Time frame: Day 1
Cormack-Lehane Grade in Patients With Head and Neck Masses Obtained With Glidescope AVL
Time frame: Day 1
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With CMAC D Blade
Time frame: Day 1
Cormack-Lehane Grade in Patients With Neck Radiation Obtained With Glidescope AVL
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23364566Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available.
- Background: PubMed 26684527Ahmad I, Bailey CR. Time to abandon awake fibreoptic intubation? Anaesthesia. 2016 Jan;71(1):12-6. doi: 10.1111/anae.13333. No abstract available.
- Background: PubMed 25764403Kramer A, Muller D, Pfortner R, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC((R)) D-BLADE) nasal awake intubation under local anaesthesia. Anaesthesia. 2015 Apr;70(4):400-6. doi: 10.1111/anae.13016.
- Background: PubMed 22487805Rosenstock CV, Thogersen B, Afshari A, Christensen AL, Eriksen C, Gatke MR. Awake fiberoptic or awake video laryngoscopic tracheal intubation in patients with anticipated difficult airway management: a randomized clinical trial. Anesthesiology. 2012 Jun;116(6):1210-6. doi: 10.1097/ALN.0b013e318254d085.
- Background: PubMed 21150569Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
- Background: PubMed 21447488Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
- Background: PubMed 22487804Fiadjoe JE, Litman RS. Difficult tracheal intubation: looking to the past to determine the future. Anesthesiology. 2012 Jun;116(6):1181-2. doi: 10.1097/ALN.0b013e318254d0a0. No abstract available.
- Background: PubMed 15321093Popat MT, Srivastava M, Russell R. Awake fibreoptic intubation skills in obstetric patients: a survey of anaesthetists in the Oxford region. Int J Obstet Anesth. 2000 Apr;9(2):78-82. doi: 10.1054/ijoa.1999.0361.
- Individual participant dataSharing planned: No
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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.
Jaime Hyman, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Intubation, run by Icahn School of Medicine at Mount Sinai 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 2 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 2 Jul 2020. 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 16 Jun 2020). 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?
Number of Participants With Cormack-Lehane Grade >2 Obtained With CMAC D Blade (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265938, which also lists 8 linked publications.
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 2 Jul 2020.