NCT04289597

Brief Summary

As a result of anatomical and physiological changes in obese patients, airway management can be challenging. Ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. In this study we planned to evaluate the measurement of neck anterior soft tissues by ultrasound in obese patients before anesthesia induction to anticipate difficult mask ventilation, difficult laryngoscopy, and intubation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

February 27, 2020

Last Update Submit

March 11, 2022

Conditions

Keywords

Difficult maskDifficult laryngoscopyDifficult intubation

Outcome Measures

Primary Outcomes (1)

  • Difficult Mask Ventilation

    Difficult mask ventilation will be evaluated with Han scale \[(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask\] and grade 3-4 will be recorded as difficult mask ventilation.

    ''1 minute'' (During anesthesia induction)

Secondary Outcomes (3)

  • Difficult laryngoscopy

    ''1 minute''

  • Difficult intubation

    ''1 minute''

  • The duration of endotracheal intubation time

    1 minute

Study Arms (1)

Obese patients

Obese patients with BMI\>30

Diagnostic Test: Distance between hyoid bone-skin (DSHB)Diagnostic Test: Vocal cord anterior commissura-skin distance (DSAC)Diagnostic Test: minimum distance of the trachea to the skin at the level of suprasternal notchDiagnostic Test: Thyroid isthmus-skin distance (DSI)Diagnostic Test: Skin-epiglottic distance (DSE)

Interventions

Distance between hyoid bone-skin

Also known as: DSHB
Obese patients

Vocal cord anterior commissura-skin distance

Also known as: DSAC
Obese patients

Distance of the trachea to the skin at the level of suprasternal notch

Also known as: DST
Obese patients

Thyroid isthmus-skin distance

Also known as: DSI
Obese patients

Skin-epiglottic distance

Also known as: DSE
Obese patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A hundred twenty-eight patients, aged 18-65 years-old, with an American Anesthesiology Association physical classification (ASA) I-III and body mass index (BMI) above 30 and planned to undergo general anesthesia for elective surgery, will be included in the study.

You may qualify if:

  • Patients planned to undergo general anesthesia for elective surgery
  • American Anesthesiology Association physical classification (ASA) status I-III
  • Body mass index (BMI) above 30

You may not qualify if:

  • Patients with neck mass
  • History of previous neck and thyroid surgery, trauma, arthritis, loss of teeth
  • History of difficult intubation
  • Bearded patients
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi Univercty

Odunpazari, Eskişehir, 26040, Turkey (Türkiye)

Location

Related Publications (7)

  • Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.

    PMID: 25403231BACKGROUND
  • Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.

    PMID: 14616599BACKGROUND
  • Liang H, Hou Y, Wei H, Feng Y. Supraglottic jet oxygenation and ventilation assisted fiberoptic intubation in a paralyzed patient with morbid obesity and obstructive sleep apnea: a case report. BMC Anesthesiol. 2019 Mar 20;19(1):40. doi: 10.1186/s12871-019-0709-7.

    PMID: 30894124BACKGROUND
  • Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.

    PMID: 23836064BACKGROUND
  • Lundstrom LH, Moller AM, Rosenstock C, Astrup G, Wetterslev J. High body mass index is a weak predictor for difficult and failed tracheal intubation: a cohort study of 91,332 consecutive patients scheduled for direct laryngoscopy registered in the Danish Anesthesia Database. Anesthesiology. 2009 Feb;110(2):266-74. doi: 10.1097/ALN.0b013e318194cac8.

    PMID: 19194154BACKGROUND
  • Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.

    PMID: 22401881BACKGROUND
  • Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.

    PMID: 31742568BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Meryem Onay, MD

    Teaching Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor-Anesthesiologist

Study Record Dates

First Submitted

February 27, 2020

First Posted

February 28, 2020

Study Start

August 20, 2020

Primary Completion

March 11, 2022

Study Completion

March 11, 2022

Last Updated

March 14, 2022

Record last verified: 2022-03

Locations