Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients

December 18, 2019 updated by: Ahmed Abdelrahman Mohamed El-Tawansy, Zagazig University

Validity Of Ultrasound As Regards Correlation To Cormack-Lehane Grading In Obese Patients: A Cross Sectional Observational Study

Since the introduction of real-time ultrasound (US) capabilities, ultrasound technology has been adopted and incorporated into daily practice by many medical and surgical specialties. Using US to help assess the difficult airway constitutes just yet another valuable application of this versatile technology . Since many anesthesia providers had already acquired proficiency in US techniques in US guided vascular access and regional nerve blocks, using US to evaluate the airway could be learned and mastered without too much difficulty. Ultrasound of the upper airway may prove to become a useful adjunct to conventional clinical assessment tools, as it has been successful in visualizing the relevant anatomy and critical structures of the airway..

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia..

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Recruiting
        • Zagazig University
        • Contact:
          • El-Tawansy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be conducted at Zagazig University Hospitals.The study is cross sectional observational study in which obese patients will be assessed using conventional clinical methods of airway assessment and by using US for the same patient before induction of anesthesia then correlated to the Cormack-Lehane finding after induction of anesthesia.

Description

Inclusion Criteria:

  • Age of the patient : (21-60) years old.
  • Sex : male & female.
  • Physical Status : The American Society of Anesthesiologists (ASA) II-III patients.
  • Body mass index : 30 to more than 30 kg / m² .
  • Operations: Laparoscopic surgeries,bariatric surgeries and any operation that requires general anesthesia with endotracheal tube placement .

Exclusion Criteria:

Patient refusal.

  • Deformity of the airway anatomy [by masses or tumors].
  • Patients with thyroid swellings 'Goitre'.
  • Pathology of the airway [edema,burn and arthritis].

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
obese patients
compare between ultrasonography and conventional clinical methods of airway assessment prior to induction of anesthesia correlating it to the Cormack-Lehane scoring system after induction of anesthesia in obese patients
Device: Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients
Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The ratio of the depth of the pre-epiglottic space (Pre-E) to the distance from the epiglottis to the mid-point of the distance between the vocal cords (E-VC).
Time Frame: through study completion, an average of 1 year
If It is [0-1] ,this suspects Cormack-Lehane Grade 1.If it is [1-2],this suspects Cormack-Lehane Grade 2.If it is [2-3],this suspects Cormack-Lehane Grade 3
through study completion, an average of 1 year
The anterior neck soft tissue thickness at the level of the vocal cords (ANS-VC)
Time Frame: through study completion, an average of 1 year
ANS-VC >0.23 cm had a sensitivity of 85.7% in predicting a Cormack-Lehan Grade 3 or 4
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The anterior neck soft tissue thickness at the level of the hyoid bone (ANS-Hyoid)
Time Frame: through study completion, an average of 1 year
If it is 1.69 cm [1.19 cm to 2.19 cm],this suspects difficult laryngoscopy.If it is 1.37cm [1.27 cm to 1.46 cm], this suspects easy laryngoscopy
through study completion, an average of 1 year
The hyomental distance of the patient in neutral position of the neck and in fully extended neck calculating the ratio between both of them
Time Frame: through study completion, an average of 1 year
If The mean hyomental distance ratios is (1.02 ± 0.01) ,this suspects difficult intubation.If it is (1.14 ± 0.02) ,this suspects easy intubation
through study completion, an average of 1 year
Tongue volume will be derived from multiplication of the midsagittal cross-sectional area of the tongue by its width obtained from transverse sonograms
Time Frame: through study completion, an average of 1 year
Large tongue volume suspects difficult laryngoscopy
through study completion, an average of 1 year
Modified Mallampati classification
Time Frame: through study completion, an average of 1 year

Class I is visualization of the hard palate, soft palate, fauces, uvula, and pillars.

Class II is visualization of the hard palate, soft palate, fauces, and base of uvula.

Class III is visualization of the hard palate and soft palate. Class IV is visualization of only the hard palate
through study completion, an average of 1 year
Interincisor gap
Time Frame: through study completion, an average of 1 year
If it is less than 5 cm (approximately three finger breadths) with limited forward protrusion of the mandible ,this is associated with increased risk of difficult laryngoscopy
through study completion, an average of 1 year
Thyromental distance
Time Frame: through study completion, an average of 1 year
If < 6cm ,this predicts difficult laryngoscopy
through study completion, an average of 1 year
Sternomental distance
Time Frame: through study completion, an average of 1 year
If < 12.5 cm ,this predicts difficult laryngoscopy
through study completion, an average of 1 year
Neck Extension and Flexion
Time Frame: through study completion, an average of 1 year
inability to extend or flex the neck suspects difficult laryngoscopy
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmed El-Tawansy, M.Sc., Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5162-23-1-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protocol and Results will be shared with other researchers.

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

anesthesiologists who are interested in airway management

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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