AzTrials
AzTrials

Intubation;DifficultNCT03671824

The Difficult Airway

An observational study of Intubation;Difficult, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intubation;Difficult
What is being tested?
Measurements
How many people
4,022 participants
Where
1 siteUnited States
Study dates
Jun 2016to 1 Dec 2019
Phase
Observational
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 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Planned awake fiberoptic intubation
  • Previous neck surgery (on bone, joint, or soft tissues in neck) or radiation
  • Obvious neck pathology/abnormality

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Parkland Health & Hospital System

    Dallas, Texas, 75235

Other trials in United States

About this study

Official title: The Difficult Airway: Incidence and Predictors in Lean vs. Obese Patients in a Large Public Teaching Hospital

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.

Read the detailed description

The study will enroll 4500 ASA physical status 1-4 patients who are scheduled to undergo surgery under general endotracheal anesthesia (GETA) at Parkland Hospital. A research assistant will identify eligible patients using the electronic medical record. After it is deemed that the patient satisfies all inclusion and exclusion criteria, the anesthesia provider or research assistant will approach the patient in the preoperative surgery holding area to ask for their permission to enroll in the study. Only study team personnel will ask potential patients for participation in the study; anesthesia providers who are not study team personnel will not be allowed to consent patients for the study. All relevant information to the study will be provided and the patient will be asked to sign an informed consent. After consent is obtained, measurements of the patient's anatomical features including thyromental distance, sternomental distance, neck circumference, interincisor distance, mandibular protrusion, and Mallampati score will be taken and recorded by the research assistant or anesthesia provider.

In the operating room, patients will have standard ASA monitors (NIBP, SpO2, EKG, ETCO2, temperature) placed. Lean patients will be placed in the standard "sniffing" position while obese patients will be placed in the "ramped" position as previously described. All patients will undergo pre-oxygenation for at least 3 minutes prior to induction of anesthesia. Patients will undergo induction of general anesthesia according to a standardized protocol that does not differ from the usual standard of care. The initial blade used for laryngoscopy will be selected by the anesthesia provider according to the characteristics of the patient as has been recommended by previous authors. After induction of general anesthesia, a research assistant will ask the anesthesia provider the degree of difficulty of mask ventilation and laryngoscopy using a standardized questionnaire modified from the intubation difficulty score. For mask ventilation, any adjunct use of equipment such as an oral airway or nasopharyngeal airway will be recorded. If two-handed ventilation is used, it will be recorded as well. The type of laryngoscope blade and Cormack-Lehane grade during laryngoscopy will be recorded. The level of training of the laryngoscopist (resident vs CRNAs vs faculty) and how many years they have been in that role will be recorded. The time from induction to intubation will also be recorded, based on the time those events are marked in the electronic medical record, as well as the lowest SpO2 that occurred between induction to intubation.

The intubation difficulty scale (IDS), which has previously been validated, will be used to score the intubation. This scale has been used in comparing difficult tracheal intubation in lean vs. obese patients.

The IDS will be comprised of 7 questions with numerical values for each question, resulting in a cumulative score. Those with an IDS score <5 will be considered "not difficult" and those with an IDS score ≥5 will be considered "difficult." A "failed intubation" will be defined as that in which the airway cannot be secured in a non-invasive fashion (e.g., cricothyrotomy) or the patient has to be awakened. The 7 questioned used to determine the IDS score will be the same as those used by Adnet et al:

  1. Number of additional intubation attempts
  2. Number of additional operators
  3. Number of alternative intubation techniques used
  4. Laryngoscopic view (Grade 1 = 0, Grade 2 = 1, Grade 3 = 2, Grade 4 = 3) Cormack Lehane grades [13]:
  • Grade 1- vocal cords completely visible
  • Grade 2- arytenoids visible but cords not completely visible
  • Grade 3- only epiglottis visible
  • Grade 4- epiglottis not visible
  1. Lifting force applied during laryngoscopy (0 if inconsiderable and 1 if considerable force used)
  2. External laryngeal pressure applied for optimized glottic exposure (0 if no, 1 if yes)
  3. Position of vocal cords at intubation (0 if abducted or not visible, 1 if adducted)

Protected patient information including name, medical record number, and date of birth will be recorded. Demographic data such as height, weight, BMI, race, and gender will also be recorded. All patients will receive a standardized general anesthetic that is usual and customary for patients undergoing their scheduled operation.

Additional information gathered will include ASA status, presence of comorbidities (e.g, OSA, HTN, DM), thyromental distance, sternomental distance, ability to protrude mandibular teeth over maxillary teeth, interincisor distance, ability to have full range of motion of the neck, Mallampati score, and neck circumference.

  • Neck circumference will be measured at the level of the cricoid cartilage with the patient's neck in neutral position.
  • Thyromental distance is thought to be an indicator of mandibular space. It will be measured as the distance from the prominentia laryngea of the thyroid cartilage to the symphysis of the mandible with the patient in maximum neck extension with the mouth closed.
  • Sternomental distance will be measured as the distance from the sternal notch to the symphysis of the mandible with the patient in maximum neck extension with the mouth closed.
  • Mallampati status will be obtained with the patient in an upright sitting position with the head in neutral position. Patients will be asked to open their mouth as wide as possible with tongue protrusion without phonation. Pharyngeal structures will be assess and classification will be performed according to the structures seen (Class 1 = soft palate, fauces, uvula, tonsillar pillars; Class 2 = soft palate, fauces, uvula; Class 3 = soft palate, base of uvula only; Class 4 = soft palate not visible).
  • The ability of the patient to protrude their lower teeth over their upper lip (upper lip bite test) will be assessed. Class 1 = lower incisors can bite the upper lip above the vermilion line; Class 2 = lower incisors can bite the upper lip below the vermilion line; Class 3 = lower incisors cannot bite the upper lip [9].
  • Neck range of motion will be graded on a binary scale. Those will full range of motion in flexion and extension will be graded as full and those without full range of motion will be graded as limited.
  • Interincisor distance will be measured as the maximum distance between the central incisors (teeth 9 and 24 or teeth 8 and 25). Patients who are edentulous will have their gum-to-gum distance recorded as the interincisor distance.
Being tested
Measurements

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MeasurementsOther

    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.

Study groups in NCT03671824
Study groupRoleWhat they receive
LeanBMI ≤ 30 kg/m2
Receives: Other: Measurements
ObeseBMI ≥30 kg/m2
Receives: Other: Measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study startJun 2016
  3. Primary completion1 Dec 2019
  4. Study completion1 Dec 2019

Resources

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
Cohort
Time perspective
Prospective
Enrolment
4,022 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671824
Sponsor's protocol ID
STU 022016-055
Status last verified
May 2020
First submitted
12 Sep 2018
Last updated
13 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9416711
  • 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.

    PubMed 19841708
  • 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.

    PubMed 11867407
  • 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.

    PubMed 16052126
  • 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.

    PubMed 22986681
  • 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.

    PubMed 11331179
  • 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.

    PubMed 12873960
  • 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.

    PubMed 19762747
  • 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.

    PubMed 19690252
  • 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.

    PubMed 11973217
  • 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.

    PubMed 15527629
  • 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.

    PubMed 21354999
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

    PubMed 6507827
  • 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.

    PubMed 8949801
  • 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.

    PubMed 4027773

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation;Difficult, run by University of Texas Southwestern Medical Center 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 5 inclusion and 9 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 May 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?

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?

The primary outcome of the study will be the incidence of difficult mask ventilation and intubation in lean vs. obese patients. (time frame: Intraoperative). 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 NCT03671824, which also lists 17 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 13 May 2020.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in