Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000131651
Ethics application status
Approved
Date submitted
5/08/2005
Date registered
12/08/2005
Date last updated
12/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Anaesthesia with propofol/morphine versus anaesthesia with propofol/remifentanil: Differences in Bronchial Mucous Transport Velocity
Scientific title
Bronchoscopic evaluation of bronchial mucus transport velocity: anaesthesia with propofol/morphine versus anaesthesia with propofol/remifentanil
Universal Trial Number (UTN)
Trial acronym
BTV3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchial mucus transport velocity 219 0
Condition category
Condition code
Anaesthesiology 246 246 0 0
Other anaesthesiology
Respiratory 247 247 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tracheobronchoscopy
Intervention code [1] 126 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 292 0
The bronchial mucus transport velocity
Timepoint [1] 292 0
Bronchoscopically assessed 30 min after placing the endotracheal tube.
Secondary outcome [1] 650 0
n/a
Timepoint [1] 650 0

Eligibility
Key inclusion criteria
ASA class 1-3; Elective, non-thoracic surgery of expected duration of more than one hour.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA >3, compromised lung function (asthma, CAL, previous lung surgery), smoking, Atopy (hay fever, allergic rhinits), medication that compromises BTV function (beta blockers, steroids, theophylline, catecholamines, atropine).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 305 0
Hospital
Name [1] 305 0
Departmental funding Royal Perth Hospital
Country [1] 305 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Country
Australia
Secondary sponsor category [1] 237 0
None
Name [1] 237 0
n/a
Address [1] 237 0
Country [1] 237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1175 0
Royal Perth Hospital
Ethics committee address [1] 1175 0
Ethics committee country [1] 1175 0
Australia
Date submitted for ethics approval [1] 1175 0
Approval date [1] 1175 0
Ethics approval number [1] 1175 0

Summary
Brief summary
Intraoperative bronchoscopic assessment of bronchial mucus transport velocity in patients having either an anaesthesia with morphine/propofol or remifentanil/propofol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36194 0
Address 36194 0
Country 36194 0
Phone 36194 0
Fax 36194 0
Email 36194 0
Contact person for public queries
Name 9315 0
Thomas Ledowski
Address 9315 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 9315 0
Australia
Phone 9315 0
+61 8 92242797
Fax 9315 0
+61 8 92241111
Email 9315 0
[email protected]
Contact person for scientific queries
Name 243 0
Thomas Ledowski
Address 243 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 243 0
Australia
Phone 243 0
+61 8 92242797
Fax 243 0
+61 8 92241111
Email 243 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.