Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000106538
Ethics application status
Approved
Date submitted
8/03/2006
Date registered
23/03/2006
Date last updated
23/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Prediction of obstructed breathing after elective surgery.
Scientific title
A case control study using 12 hour continuous respiratory monitoring to assess the prediction of frequent upper airway obstructions after elective surgery by preoperative airway evaluation and risk score for obstruvtive sleep apnoea.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 1069 0
Postoperative respiratory obstruction 1070 0
Condition category
Condition code
Respiratory 1150 1150 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Continuous respiratory monitoring 8 hours with Somte portable monitor. Identification of risk factors at pre-operative assessment.
Intervention code [1] 931 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 1546 0
Frequency of respiratory events per hour.
Timepoint [1] 1546 0
Per hour.
Secondary outcome [1] 2792 0
Association with OSA risk factors and airway examination.
Timepoint [1] 2792 0
Risk factors will be evaluated at the preoperative clinic, 1-2 weeks prior to surgery.
Secondary outcome [2] 2793 0
Continuous respiratory monitoring.
Timepoint [2] 2793 0
Applied for 12 hours, commencing in the postoperative recovery area.

Eligibility
Key inclusion criteria
Assessed prior to elective surgery, able to provide informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac or thoracic surgery, elective postoperative ventilation, previous diagnosis of obstructive sleep apnoea and use of CPAP, day or short-stay surgery.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1255 0
Hospital
Name [1] 1255 0
Royal Melbourne Hospital, Hospital auxilliary
Country [1] 1255 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia
Address
Country
Secondary sponsor category [1] 1114 0
Hospital
Name [1] 1114 0
Royal Melbourne Hospital
Address [1] 1114 0
Country [1] 1114 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Up to 20% of patients over 50yr presenting for elective surgery may have episodes of obstructed breathing e.g. snoring, which is likely to worsen and become a significant risk after surgery. Use of a recorder to continuously monitor breathing for the 12 hours immediately after surgery may help us to identify the most useful risk factors to look for during the assessment of patients at the clinic prior to surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35560 0
Address 35560 0
Country 35560 0
Phone 35560 0
Fax 35560 0
Email 35560 0
Contact person for public queries
Name 10120 0
Dr Duncan W Blake
Address 10120 0
Department of Anaesthesia
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 10120 0
Australia
Phone 10120 0
+61 3 93427925
Fax 10120 0
Email 10120 0
[email protected]
Contact person for scientific queries
Name 1048 0
Dr Duncan W Blake
Address 1048 0
Department of Anaesthesia
Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 1048 0
Australia
Phone 1048 0
+61 3 93427925
Fax 1048 0
Email 1048 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.