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Airway Ultrasonography Measurements With Cormack Lehane Classification in Patients With OSA

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ClinicalTrials.gov Identifier: NCT03899519
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Rhendra Hardy Mohamad Zaini, University of Science Malaysia

Brief Summary:
Airway assessment using ultrasonography can provide an additional information in identifying difficult intubation in OSA patients. The main purpose of this study is to find the correlation of the ultrasound parameters and the Cormack Lehane Score (CL Score) as well as to identify the cut-off point of the ultrasound parameters that would differentiate between the easy and difficult intubation.

Condition or disease
Obstructive Sleep Apnea Difficult Intubation

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Correlations of the Findings Obtained From Airway Ultrasonography With Cormack Lehane Classification in Patients With Obstructive Sleep Apnoea - A Cross Sectional Study
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. Correlation between airway ultrasonography measurements and CL score [ Time Frame: may 2017-may 2018 ]
    ultrasound measurements (PE, EVC, PE/EVC - refer study descriptions)

  2. Cut off point of airway ultrasonography measurement in predicting the difficulty in intubation using CL [ Time Frame: may 2017-may 2018 ]
    ultrasound measurements (PE, EVC, PE/EVC - refer study descriptions)

  3. Accuracy of each cut off point in objective 2 [ Time Frame: may 2017-may 2018 ]
    cut off point to differentiate between easy and difficult intubation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patient age between 18 to 65, diagnosed or suspected OSA, planned for operation under General Anaesthesia
Criteria

Inclusion Criteria:

  1. Age between 18-65
  2. Diagnose / screened OSA
  3. Planned for operation under General Anaesthesia
  4. American Society Of Anaesthesia (ASA) physical status class I-III

Exclusion Criteria:

  1. Unstable haemodynamic status
  2. Patient refusal to participate
  3. Altered mental status, cognitive function or mental disorder
  4. Distorted head and neck anatomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899519


Locations
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Malaysia
University of Science Malaysia Hospital
Kubang Kerian, Kelantan, Malaysia, 16150
Sponsors and Collaborators
University of Science Malaysia
Investigators
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Principal Investigator: Rhendra Hardy Mohamed Zaini University Sains Malaysia

Publications of Results:
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Responsible Party: Rhendra Hardy Mohamad Zaini, Senior Consultant Anaesthetist and Lecturer, University of Science Malaysia
ClinicalTrials.gov Identifier: NCT03899519     History of Changes
Other Study ID Numbers: USM/JEPeM/18010094
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rhendra Hardy Mohamad Zaini, University of Science Malaysia:
OSA
ultrasound
airway
difficult intubation

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases