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Obese PatientsNCT04140357

Role of Ultrasonography in Airway Management

An observational study of Obese Patients, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obese Patients
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2019to 1 Mar 2020
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with obesity body mass index >30 undergoing surgery and requiring tracheal intubation

Who may be able to join

  • BMI>30
  • 18-65 YEARS
  • ASA 1-2-3
  • Obese patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Basak Gulel contact

05061436261

dr.basakdemir@gmail.com

Emine Arik contact

05333471530

emineincearik@yahoo.com

Turkey (Türkiye)1 site

  • Başak Gülel

    Ankara, Province, 06080

Other trials in Turkey (Türkiye)

About this study

Official title: Is There a Role for Ultrasonography in the Airway Management of Patients With Obesity

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.

Read the detailed description

In this prospective and randomized controlled study, mallampati scores, interincisor gap, thyromental distance, neck circumference measurement and upper lip bite test scores will be recorded in sixty obese patients.

Additionally, neck tissue thickness will be recorded at 4 different levels (hyoid bone-skin distance, epiglot-skin distance , thyroid istmus-skin distance, vocal cord-skin distance) after the sniffing position by ultrasound with the linear probe. All measurements will be repeated three times and an average values will be recorded.

After all this measurements, endotracheal intubation will be performed by an experienced anesthetist who is uninformed about study. During intubation the Cormack Lehane (C/L, grade 1: full view of the vocal cords; grade 2a: partial view of the glottis; 2b: posterior part of the vocal cord and arytenoids visible; grade 3: only epiglottis visible; and grade 4: neither epiglottis nor glottis visible) and the Intubation Difficulty Scale (IDS) score (the numbers of attempts, operators, and alternative techniques used, the C/L grade of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords. Every insertion of the laryngoscope and advancement of the tracheal tube towards the glottis counted as an attempt. A score of >5 indicates moderate-to-major difficulty) will be recorded.

Conditions
Obese Patients

What is being measured

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

  1. 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

    Measured: 30 minutes before induction

  2. Epiglottis-skin distance

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

    Measured: 30 minutes before induction

  3. Thyroid isthmus-skin distance

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

    Measured: 30 minutes before induction

  4. Vocal cord-skin distance

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

    Measured: 30 minutes before induction

Secondary outcomes (1)

  1. Intubation difficulty scale score

    Each number of numbers attempt, operator and alternative techniques used, the Cormack Lehane score of laryngoscopic view, lifting force and external laryngeal manipulation required, and position of the vocal cords count 1 point. A score of >5 indicates moderate-to-major difficulty

    Measured: 1 minutes after intubation

Timeline

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

  1. First posted25 Oct 2019
  2. Study start1 Nov 2019 (estimated)
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion1 Mar 2020 (estimated)

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
Other
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140357
Sponsor's protocol ID
BasakUltrasonografi
Status last verified
Oct 2019
First submitted
16 Oct 2019
Last updated
25 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26705531

  • 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.

    PubMed 25403231

  • 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.

    PubMed 14616599

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Obese Patients, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Oct 2019. 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 Turkey (Türkiye). 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Basak Gulel (05061436261, dr.basakdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hyoid bone-skin distance -effect of ultrasound on prediction of difficult laryngoscopy (time frame: 30 minutes before induction). The study lists 4 primary outcomes in all. 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 NCT04140357, which also lists 4 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 25 Oct 2019.

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