The Incidence of Undiagnosed OSA Compared in Multi-ethic Races of Malaysia & the Associated Postoperative Complications

May 6, 2014 updated by: Wang Chew Yin, University of Malaya

The Incidence of Undiagnosed OSA in Multi-ethic Races of Malaysia and the Associated Postoperative Complications

Obstructive sleep apnoea (OSA) is a condition in which a person's sleep is disrupted with momentary periods of apnoea and hypopnoea. This occurs when there is a blockage to airflow. When this happens, the patient will snore, gasp or choke in the attempt to attain more oxygen. This results in disrupted sleep and the patient may even awake from sleep.

It has been found that a great proportion of Malaysians have habitual snoring and with the increase in obesity over the years, it is a concern that OSA may be prevalent in Malaysia.

However, it has been seen that OSA is commonly undiagnosed in patient. This poses a worry because these people can come in for surgery. Diagnosis of OSA before surgery is important in order to prepare for the complication related to OSA.

Study Overview

Status

Unknown

Conditions

Detailed Description

Research staff will interview and examine patients and review their charts to obtain information on patient characteristics. Patients will also be assessed using STOP-BANG Questionnaire & Epworth Sleepiness Scale.

Anaesthesia and surgery will be performed according to routine standard of care.

Drugs used during anaesthesia, postoperative analgesia and hemodynamic data will be recorded.

During their stay in hospital, patients will be followed daily, and outcomes will be recorded, until discharge. Data on medications will be recorded.

Study Type

Observational

Enrollment (Anticipated)

1000

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 Backup

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
        • University Malaya Medical Centre
        • Sub-Investigator:
          • Hou Yee Lai, MBBS
        • Sub-Investigator:
          • Tawadod HA Abdalla, MBBS
        • Sub-Investigator:
          • Xue Lin Chan, A-level
        • Sub-Investigator:
          • CY Lean, MBBS
        • Sub-Investigator:
          • Sook Hui Chaw, MD

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients over age 18 undergoing non-cardiac surgery

Description

Inclusion Criteria:

  • adult males and females
  • age ≥ 18 years
  • undergoing elective surgery ( general,regional or local anaesthesia with monitored anaesthesia care)

Exclusion Criteria:

  • previous diagnosis of OSA or any sleep-related breathing disorder
  • they are unwilling
  • their surgery included tonsillectomy, septoplasty, uvloplasty, pharyngoplasty, tracheostomy, or prolonged mechanical ventilation

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
Patients with OSA
Post operative patients with OSA
Post-operative Patients without OSA
All post operative patients without OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of OSA
Time Frame: 30 days
Incidence of OSA in surgical patients among the ethnic races.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: 30 days
Any cardiovascular or respiratory complications detected during the post-operative period.
30 days

Collaborators and Investigators

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

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Chew Yin Wang, MBChB, University of Malaya

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

May 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1017.8

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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