NCT05896098

Brief Summary

Introduction and Purpose: Obesity is an increasing public health problem all over the world. Obesity is a proinflammatory multisystemic disease defined as hypertrophy and/or hyperplasia of adipose tissue. Obesity is frequently encountered in elective and emergency surgical procedures and causes more difficulties in airway management. Difficult airway, characterized by difficult mask ventilation and difficult intubation, is especially common in obese and morbidly obese patients. Some studies show that the measurement of anterior neck soft tissue thickness at the level of the vocal cords plays an important role in estimating difficult laryngoscopy in obese patients. Difficult intubation is envisaged in patients with pretracheal soft tissue thickness of 28 mm and neck circumference of more than 50 cm at the level of the vocal cord. In this prospective observational study, it is aimed to measure the preoperative anterior cervical soft tissue thickness with 3 parameters by USG in obese patients undergoing elective surgery, and to evaluate the relationship of these values with the Han Scale and Cormack-Lehane classification and their effectiveness as an indicator of difficult airway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

March 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

May 10, 2023

Last Update Submit

June 21, 2023

Conditions

Keywords

obesity ultrasound difficult airway

Outcome Measures

Primary Outcomes (1)

  • Difficult laryngoscopy

    To determine the difficult airway in obese patients with 3 levels of anterior soft tissue measurement (cm) with ultrasound.

    preoperative evaluation

Secondary Outcomes (1)

  • Difficult mask ventilation

    preoperative evaluation

Study Arms (2)

Easy laryngoscopy

Cormack Lehane Classification 1-2a

Other: Ultrasound

Difficult laryngoscopy

Cormack Lehane Classification 2b-3-4

Other: Ultrasound

Interventions

Measurement of the airway by ultrasound in obese patients.

Difficult laryngoscopyEasy laryngoscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

obese elective surgery patients

You may qualify if:

  • Elective surgery, ages between 18-80 BMI over 30, ASA I-II

You may not qualify if:

  • Facial and cervical trauma, head and neck malignancy, tracheostomy and thyroid surgery, non-cooperate patients, parturients, difficult airway history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

Medical faculty

Balıkesir, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Obesity

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Nazan Kocaoglu

    Balikesir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 9, 2023

Study Start

March 1, 2020

Primary Completion

March 30, 2022

Study Completion

August 30, 2022

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations