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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02127099
• Other study ID #: 1017.8
• Status: Not yet recruiting
• Phase: N/A
• First received: April 25, 2014
• Last updated: May 6, 2014
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: University of Malaya
• Contact: Chew Yin Wang, MBChB
• Phone: 60192340232
• Email: wangcy1836[@]gmail.com
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Postoperative Complications
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of OSA	Incidence of OSA in surgical patients among the ethnic races.	30 days	No
Secondary	Post-operative complications	Any cardiovascular or respiratory complications detected during the post-operative period.	30 days	No