The Difficult Airway
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03671824 |
Recruitment Status :
Completed
First Posted : September 14, 2018
Last Update Posted : May 13, 2020
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Condition or disease | Intervention/treatment |
---|---|
Intubation;Difficult | Other: Measurements |

Study Type : | Observational |
Actual Enrollment : | 4022 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Difficult Airway: Incidence and Predictors in Lean vs. Obese Patients in a Large Public Teaching Hospital |
Actual Study Start Date : | June 2016 |
Actual Primary Completion Date : | December 1, 2019 |
Actual Study Completion Date : | December 1, 2019 |
Group/Cohort | Intervention/treatment |
---|---|
Lean
BMI ≤ 30 kg/m2
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Other: Measurements
Physiologic measurements including but not limited to thyromental distance, sternomental distance, Mallampati score, mouth opening, interincisor distance, and mandibular protrusion will be measured and recorded. All measurements are non invasive. |
Obese
BMI ≥30 kg/m2
|
Other: Measurements
Physiologic measurements including but not limited to thyromental distance, sternomental distance, Mallampati score, mouth opening, interincisor distance, and mandibular protrusion will be measured and recorded. All measurements are non invasive. |
- The primary outcome of the study will be the incidence of difficult mask ventilation and intubation in lean vs. obese patients. [ Time Frame: Intraoperative ]Incidence of DI and DMV

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 18-80 years old
- ASA physical status classification 1 to 4
- Scheduled for an operation that requires general endotracheal anesthesia
- Willing and able to consent in English or with use of appropriate language translator
- Anesthesia providers who are caring for patients who have enrolled in the study will also be potential subjects who will be verbally consented and asked to fill out a questionnaire.
Exclusion Criteria:
- Age less than 18 or older than 80
- Unable to give informed consent for participation in the study
- Stat cases
- Patients who will not be expected to have general anesthesia (e.g., monitored anesthesia care or regional anesthesia)
- Patient refusal
- History of difficult intubation
- Planned awake fiberoptic intubation
- Previous neck surgery (on bone, joint, or soft tissues in neck) or radiation
- Obvious neck pathology/abnormality

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671824
United States, Texas | |
Parkland Health & Hospital System | |
Dallas, Texas, United States, 75235 |
Principal Investigator: | Tiffany Moon, MD | University of Texas Southwestern Medical Center |
Responsible Party: | Tiffany B Moon, Associate Professor, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT03671824 |
Other Study ID Numbers: |
STU 022016-055 |
First Posted: | September 14, 2018 Key Record Dates |
Last Update Posted: | May 13, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |