Anesthesia Intubation ComplicationNCT04864106
Comprehensive Preoperative Airway Grading
A study testing Endoscopic Examination in people with Anesthesia Intubation Complication, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Purpose of study: To contrast and compare the Mallampatti test to a comprehensive airway grading test using a rigid 75-degree angle laryngoscope (CPAG) Study Hypothesis: The investigators hypothesize that the CPAG will have greater sensitivity and specificity for predicting difficulty laryngoscopy as compared to the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- Endoscopic Examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- 18+
- ASA status 1-4
Who cannot join
- <18
- patients unwilling to do the comprehensive airway examination
- patients unable to do the comprehensive airway examination
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of study: To contrast and compare the Mallampatti test to a comprehensive airway grading test using a rigid 75-degree angle laryngoscope (CPAG) Study Hypothesis: The investigators hypothesize that the CPAG will have greater sensitivity and specificity for predicting difficulty laryngoscopy as compared to the Mallampati test.
The investigators plan to test this hypothesis by comparing the correlation of (a) airway Mallampati airway grading (predicted airway difficulty) versus (b) CPAG view grading and Cormack Laryngoscopy assessment (observed airway difficulty).
Read the detailed description
The purpose of this study is to evaluate a comprehensive preoperative airway examination using a 75-degree rigid laryngoscope. (It is important to note that this laryngoscope is routinely used in the speech pathology clinic where patients are not required to provide a written consent because of the limited and non-invasive nature of the examination) The investigators plan to accomplish this by grading a person's airway using a laryngoscopy view and obtain pictures to describe a person's supraglottic airway. The investigators will use these measures to assist the anesthesiologists of the day of surgery with the approach of securing the airway (traditional laryngoscopy versus video-assisted laryngoscopy versus fiberoptic-guided laryngoscopy).
The traditional test and parameters for the assessment of the airway are: The Mallampatti test, the Wilson airway assessment, evaluation of the atlantooccipital joint extension (neck mobility), the thyro-mental distance, the sterno-mental distance, mandibulo-hyoid distance, inter-incisor distance (mouth opening). Other investigators have proposed the use of radiographic assessment methods. These traditional tests are limited by the inability to visualize the posterior pharynx, tongue base, and glottis. Difficulty in intubation can be classified according to the view obtained during direct laryngoscopy into 4 grades. These four grades of laryngoscopic views were defined by Cormack and Lehane. At the present time, no single airway test can provide a high index of sensitivity and specificity for the prediction of a difficult airway. Therefore, it is common practice to use a combination of multiple tests and accept that there is still ambiguity when predicting airway challenges and the best approach to securing an airway.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- Endoscopic Examination
- Keywords
- Airway Grading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ExaminationDevice
Endoscopic airway grading using a rigid 75-degree angle laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants will undergo a endoscopic airway assessment in addition to the airway classification using the Mallampati score. Receives: Device: Endoscopic Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants comparison of grading scores on the traditional procedure verses the comprehensive airway grading
Cormack-Lehane system- Grading I-IV looking at the Vocal Cords and Epiglottis (1 is less restricted visibility, 4 is most restricted visibility)
Measured: Preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start6 Nov 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We are adding a direct laryngoscopy based airway examination to the routine patient examination. Investigators will have two (complementary) methods of a preoperative airway examination; (a) the traditional Malampati airway examination and (b) the new laryngoscopy based examination. Both airway examination methods will be correlated with the airway grading during the induction of anesthesia (Cormack airway grading). The correlation strength of these two preoperative airway assessment methods and the intraoperative Cormack airway grading will be compared.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Froelich, University of Alabama at Birmingham
- Investigators
- Michael Froelich, MD, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864106
- Sponsor's protocol ID
- IRB-300004915
- Other IDs
- UAB
- Status last verified
- Jun 2025
- First submitted
- 5 Nov 2020
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Preoperative Airway Grading
- ClinicalTrials.gov ID
- NCT04864106
- Acronym / sponsor ID
- IRB-300004915
- Conditions
- Anesthesia Intubation Complication
- Keywords
- Airway Grading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of study: To contrast and compare the Mallampatti test to a comprehensive airway grading test using a rigid 75-degree angle laryngoscope (CPAG) Study Hypothesis: The investigators hypothesize that the CPAG will have greater sensitivity and specificity for predicting difficulty laryngoscopy as compared to the Mallampati test.
The investigators plan to test this hypothesis by comparing the correlation of (a) airway Mallampati airway grading (predicted airway difficulty) versus (b) CPAG view grading and Cormack Laryngoscopy assessment (observed airway difficulty).
Detailed description
The purpose of this study is to evaluate a comprehensive preoperative airway examination using a 75-degree rigid laryngoscope. (It is important to note that this laryngoscope is routinely used in the speech pathology clinic where patients are not required to provide a written consent because of the limited and non-invasive nature of the examination) The investigators plan to accomplish this by grading a person's airway using a laryngoscopy view and obtain pictures to describe a person's supraglottic airway. The investigators will use these measures to assist the anesthesiologists of the day of surgery with the approach of securing the airway (traditional laryngoscopy versus video-assisted laryngoscopy versus fiberoptic-guided laryngoscopy).
The traditional test and parameters for the assessment of the airway are: The Mallampatti test, the Wilson airway assessment, evaluation of the atlantooccipital joint extension (neck mobility), the thyro-mental distance, the sterno-mental distance, mandibulo-hyoid distance, inter-incisor distance (mouth opening). Other investigators have proposed the use of radiographic assessment methods. These traditional tests are limited by the inability to visualize the posterior pharynx, tongue base, and glottis. Difficulty in intubation can be classified according to the view obtained during direct laryngoscopy into 4 grades. These four grades of laryngoscopic views were defined by Cormack and Lehane. At the present time, no single airway test can provide a high index of sensitivity and specificity for the prediction of a difficult airway. Therefore, it is common practice to use a combination of multiple tests and accept that there is still ambiguity when predicting airway challenges and the best approach to securing an airway.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We are adding a direct laryngoscopy based airway examination to the routine patient examination. Investigators will have two (complementary) methods of a preoperative airway examination; (a) the traditional Malampati airway examination and (b) the new laryngoscopy based examination. Both airway examination methods will be correlated with the airway grading during the induction of anesthesia (Cormack airway grading). The correlation strength of these two preoperative airway assessment methods and the intraoperative Cormack airway grading will be compared.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Endoscopic ExaminationParticipants will undergo a endoscopic airway assessment in addition to the airway classification using the Mallampati score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female
- 18+
- ASA status 1-4
Key exclusion criteria (3 listed)
- <18
- patients unwilling to do the comprehensive airway examination
- patients unable to do the comprehensive airway examination
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 |
|---|---|---|
| Endoscopic ExaminationEndoscopic airway grading using a rigid 75-degree angle laryngoscope. | Device | Study Group |
Primary outcome
Participants comparison of grading scores on the traditional procedure verses the comprehensive airway grading
Time frame: Preoperatively
Cormack-Lehane system- Grading I-IV looking at the Vocal Cords and Epiglottis (1 is less restricted visibility, 4 is most restricted visibility)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No. To be determined.
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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.
Michael Froelich, MD, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Examination in people with Anesthesia Intubation Complication, run by University of Alabama at Birmingham 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 3 inclusion and 3 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 13 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participants comparison of grading scores on the traditional procedure verses the comprehensive airway grading (time frame: Preoperatively). 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 13 Jun 2025.