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The Difficult Airway

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671824
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tiffany B Moon, University of Texas Southwestern Medical Center

Brief Summary:
Patients who are obese, as defined by a BMI ≥ 30 kg/m2 may be more difficult to intubate than non-obese patients. Traditional methods of airway assessment such as Mallampati score, mouth opening, and thyromental distance may not be the best predictors of difficult intubation. Patients who are scheduled to have non-stat surgery at Parkland Memorial Hospital will be asked to participate in this study and sign a written consent form. 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 remaining aspects of perioperative care, including the general anesthetic technique, will be standardized for all patients and will not differ from the standard of care. There will be no incentive or payment to the patients. This prospective study is intended to enroll 4500 consecutive surgical patients. Lean patients (BMI < 30 kg/m2) who are intubated by the same anesthesia providers during the same time period will be included as the control group and to report the incidence of difficult mask ventilation and difficult intubation in our general surgical population, which has not previously been defined.

Condition or disease Intervention/treatment
Intubation;Difficult Other: Measurements

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Study Type : Observational
Estimated Enrollment : 4500 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Group/Cohort Intervention/treatment
Lean
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.

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
Study Population
Patients who are scheduled to have non-stat surgery at Parkland Memorial Hospital.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Taylor Pak, BS 469-419-5790

Locations
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United States, Texas
Parkland Health & Hospital System Recruiting
Dallas, Texas, United States, 75235
Contact: Tiffany Moon, MD    469-419-5790      
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Tiffany Moon, MD University of Texas Southwestern Medical Center

Publications:

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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: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No