NCT04524546

Brief Summary

Difficulties airway significantly contribute to the morbidity and mortality associated with anesthesia. Identifying situations and patients at risk for airway management problems is the key to optimal care and has been the focus of numerous publications. Although controversial, Body Mass Index (BMI) is considered as associated with difficult intubation in both and operating theaters. A modified measurement of SMD is obtained with the head in neutral position (SMD neutral), then the difference between SMD extension and SMD neutral was calculated and it was referred to as sternomental displacement (SMDD). SMDD was proved to be a good objective predictor for difficult laryngoscopy in adult patients, and its predictive ability was increased when combined with other tests as neck circumference (NC). To the best of our knowledge, the validity of the SMDD test was not previously assessed in obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

August 20, 2020

Last Update Submit

May 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • A a cut-off value, sensitivity (Sn), specificity (Sp), positive predictive values (PPV), negative predictive values (NPV) of sternomental displacement in predicting difficult laryngoscopy in obese patient undergoing GA.

    before induction of general anesthesia

Interventions

While the patient is in sitting position, (SMD neutral) will be is measured using tape as the distance between upper borders of the manubrium sterni to the mentum with the head in a neutral position. The (SMD extension) will be then measured in the same way with the head extended on the neck. The difference between SMD extension and SMD neutral will be then calculated as sternomental displacement (SMDD).

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI \> 30 Kg/m2

You may qualify if:

  • Patients of either sex, aged between 18-60 years old, ASA physical status II \& III with BMI \> 30 Kg/m2 undergoing elective surgical procedures under general anesthesia using endotracheal intubation by conventional laryngoscopy.

You may not qualify if:

  • neuromuscular disorders, craniofacial abnormalities, abnormal dentition, lesions or scares in head and neck limiting the neck mobility, uncooperative, who needed awake intubation and patients who underwent emergency operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia department - Faculty of medicine- Cairo University

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine

Study Record Dates

First Submitted

August 20, 2020

First Posted

August 24, 2020

Study Start

September 1, 2020

Primary Completion

February 20, 2021

Study Completion

April 30, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Locations