The Difficult Airway

NCT03671824 | Completed DMC

• 1 other identifier: STU 022016-055
• Study Type: observational
• Target: 4,022
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study will be the incidence of difficult mask ventilation and intubation in lean vs. obese patients.

  Incidence of DI and DMV

  Intraoperative

Study Arms (2)

Lean

BMI ≤ 30 kg/m2

Other: Measurements

Obese

BMI ≥30 kg/m2

Other: Measurements

Interventions

Measurements OTHER

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.

Lean; Obese

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (17)

• Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.

  PMID: 9416711 BACKGROUND

• Braz LG, Braz DG, Cruz DS, Fernandes LA, Modolo NS, Braz JR. Mortality in anesthesia: a systematic review. Clinics (Sao Paulo). 2009;64(10):999-1006. doi: 10.1590/S1807-59322009001000011.

  PMID: 19841708 BACKGROUND

• Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.

  PMID: 11867407 BACKGROUND

• Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005 Aug;103(2):429-37. doi: 10.1097/00000542-200508000-00027.

  PMID: 16052126 BACKGROUND

• Sturm R, Hattori A. Morbid obesity rates continue to rise rapidly in the United States. Int J Obes (Lond). 2013 Jun;37(6):889-91. doi: 10.1038/ijo.2012.159.

  PMID: 22986681 BACKGROUND

• Benumof JL. Obstructive sleep apnea in the adult obese patient: implications for airway management. J Clin Anesth. 2001 Mar;13(2):144-56. doi: 10.1016/s0952-8180(01)00232-x.

  PMID: 11331179 BACKGROUND

• Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin JL, Desmonts JM. Difficult tracheal intubation is more common in obese than in lean patients. Anesth Analg. 2003 Aug;97(2):595-600. doi: 10.1213/01.ANE.0000072547.75928.B0.

  PMID: 12873960 BACKGROUND

• Neligan PJ, Porter S, Max B, Malhotra G, Greenblatt EP, Ochroch EA. Obstructive sleep apnea is not a risk factor for difficult intubation in morbidly obese patients. Anesth Analg. 2009 Oct;109(4):1182-6. doi: 10.1213/ane.0b013e3181b12a0c.

  PMID: 19762747 BACKGROUND

• Khan ZH, Mohammadi M, Rasouli MR, Farrokhnia F, Khan RH. The diagnostic value of the upper lip bite test combined with sternomental distance, thyromental distance, and interincisor distance for prediction of easy laryngoscopy and intubation: a prospective study. Anesth Analg. 2009 Sep;109(3):822-4. doi: 10.1213/ane.0b013e3181af7f0d.

  PMID: 19690252 BACKGROUND

• Turkan S, Ates Y, Cuhruk H, Tekdemir I. Should we reevaluate the variables for predicting the difficult airway in anesthesiology? Anesth Analg. 2002 May;94(5):1340-4, table of contents. doi: 10.1097/00000539-200205000-00055.

  PMID: 11973217 BACKGROUND

• Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.

  PMID: 15527629 BACKGROUND

• Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.

  PMID: 21354999 BACKGROUND

• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

  PMID: 6507827 BACKGROUND

• Al Ramadhani S, Mohamed LA, Rocke DA, Gouws E. Sternomental distance as the sole predictor of difficult laryngoscopy in obstetric anaesthesia. Br J Anaesth. 1996 Sep;77(3):312-6. doi: 10.1093/bja/77.3.312.

  PMID: 8949801 BACKGROUND

• Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.

  PMID: 4027773 BACKGROUND

• Sheff SR, May MC, Carlisle SE, Kallies KJ, Mathiason MA, Kothari SN. Predictors of a difficult intubation in the bariatric patient: does preoperative body mass index matter? Surg Obes Relat Dis. 2013 May-Jun;9(3):344-9. doi: 10.1016/j.soard.2012.02.004. Epub 2012 Mar 3.

  PMID: 22475762 BACKGROUND

• Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.

  PMID: 17182981 BACKGROUND

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Tiffany Moon, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: June 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)