NCT04140357

Brief Summary

Ultrasound is one of the most useful devices in daily anesthesia practice. Latest purpose of ultrasound usage is prediction of difficult intubation. In this study, we aimed to predict difficult laryngoscopy and intubation by using ultrasound measurement of neck soft tissue thickness in obese patient preoperatively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 16, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

October 16, 2019

Last Update Submit

October 24, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Hyoid bone-skin distance -effect of ultrasound on prediction of difficult laryngoscopy

    The hyoid bone-skin distance will be measured by using ultrasound in centimeters

    30 minutes before induction

  • Epiglottis-skin distance

    The epiglottis-skin distance will be measured by using ultrasound in centimeters

    30 minutes before induction

  • Thyroid isthmus-skin distance

    The thyroid isthmus-skin distance will be measured by using ultrasound in centimeters

    30 minutes before induction

  • Vocal cord-skin distance

    The vocal cord-skin distance will be measured by using ultrasound in centimeters

    30 minutes before induction

Secondary Outcomes (1)

  • Intubation difficulty scale score

    1 minutes after intubation

Eligibility Criteria

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

Patients with obesity body mass index \>30 undergoing surgery and requiring tracheal intubation

You may qualify if:

  • BMI\>30
  • YEARS
  • ASA 1-2-3
  • Obese patients

You may not qualify if:

  • Pregnancy
  • Upper airway pathology
  • Cervical spine pathology
  • Laryngeal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başak Gülel

Ankara, Province, 06080, Turkey (Türkiye)

Location

Related Publications (4)

  • Al-Qasmi A, Al-Alawi W, Malik AM, Manzoor Khan R, Kaul N. Comparison of Tracheal Intubation Using the Storz's C-Mac D-blade(TM) Video-Laryngoscope Aided by Truflex(TM) Articulating Stylet and the Portex(TM) Intubating Stylet. Anesth Pain Med. 2015 Dec 5;5(6):e32299. doi: 10.5812/aapm.32299. eCollection 2015 Dec.

    PMID: 26705531BACKGROUND
  • 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.

  • 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.

  • 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.

Study Officials

  • Basak Gulel

    Sbü Dışkapı Yıldırım Beyazıt Eğitim Ve Araştırma Hastanesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 25, 2019

Study Start

November 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations