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Trial registered on ANZCTR


Registration number
ACTRN12616000614493
Ethics application status
Approved
Date submitted
1/05/2016
Date registered
11/05/2016
Date last updated
15/03/2019
Date data sharing statement initially provided
15/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Fluid status after bowel preparation for colonoscopy: objective assessment and relationship to hypotension under sedation
Scientific title
Fluid status after bowel preparation for colonoscopy: objective assessment and relationship to hypotension under sedation
Secondary ID [1] 289113 0
None
Universal Trial Number (UTN)
Universal Trial Number (UTN) is U1111-1182-4670
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endoscopy
298581 0
dehydration 298582 0
Condition category
Condition code
Anaesthesiology 298659 298659 0 0
Anaesthetics
Oral and Gastrointestinal 298748 298748 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In patients who have taken bowel preparation solution for an endoscopy examination (colonoscopy +/- gastroscopy) their intravascular fluid status will be assessed using echocardiography views before and after passive leg raise testing. The volume assessment will take approximately 20minutes and occur immediately prior to the endoscopy procedure start. This aims to determine if patients are intravascularly deplete prior to endoscopy examination.

All assessments will be completed on the day of the procedure.
Intervention code [1] 294618 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298154 0
The proportion of patients who are intravascularly deplete as assessed by a positive Passive Leg Raise (PLR) test on TTE (greater than or equal to 15% increase in the sub-aortic velocity time index)
Timepoint [1] 298154 0
Assessment on the day of endoscopy prior to endoscopy commencement
Secondary outcome [1] 323304 0
Intravascular volume depletion measured on echocardiography by assessment of inferior vena cava collapsibility
Timepoint [1] 323304 0
On the day of endoscopy prior to examination commencement
Secondary outcome [2] 323305 0
Quality of recovery (assessed using the QoR-15) following endoscopy in patients who are intravascularly deplete compared to those with normal intravascular volume status prior to endoscopy
Timepoint [2] 323305 0
At the time of hospital discharge following endoscopy
Secondary outcome [3] 323306 0
The rate of hypotension (Systolic BP less than 90mmHg or 25% decrease from baseline) during endoscopy in patients who are intravascularly deplete (positive primary outcome) compared to those that have normal intravascular volume status. Blood pressure will be measured by automatic sphygnomanometer on a 2.5 minutely cycle.
Timepoint [3] 323306 0
TTE performed immediately prior to endoscopy examination and blood pressure measured throughout the endoscopy procedure at 2.5 minute intervals.

Eligibility
Key inclusion criteria
1. Electively booked endoscopy procedure
2. Adult patients undergoing endoscopy procedures where bowel preparation solution has been administered (colonoscopy, gastroscopy combined with colonoscopy with both diagnostic and therapeutic intent including polypectomy)
3. Language and cognitive ability to understand and comply with study requirements
4. No local injury or contraindication to the use of transthoracic echocardiography (TTE) imaging
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Emergency procedures
2. Patients undergoing endoscopy without receiving, or not completing, bowel preparation solution
3. Patients with language or cognitive barriers to full understanding of the study procedures and the ability to obtain consent
4. Patients undergoing advanced endoscopic procedures (ERCP, enteroscopy, endoscopy via stoma, banding haemorrhoidectomy)
5. Contraindication to the use of transthoracic echocardiography

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As this is the first assessment of the intravascular fluid status of patients following bowel preparation by TTE and a non-invasive cardiac output device reliable sample size calculation isn’t possible. However, a study addressing a similar question (effect of fasting on volume status) and utilizing the same primary end point was conducted in 100 patients.
100 patients should allow for meaningful assessment of the cohort under study even with incomplete data collection that is an anticipated problem due to the patient dependent nature of TTE measurements.

The change in the measured haemodynamic variables from baseline to after passive leg raising will be reported with their 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5706 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 13194 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 293486 0
Hospital
Name [1] 293486 0
Royal Melbourne Hospital
Address [1] 293486 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Country [1] 293486 0
Australia
Funding source category [2] 302246 0
Charities/Societies/Foundations
Name [2] 302246 0
Australian and New Zealand College of Anaesthetists
Address [2] 302246 0
ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,
Australia
Country [2] 302246 0
Australia
Primary sponsor type
Individual
Name
Megan Allen
Address
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Country
Australia
Secondary sponsor category [1] 292310 0
None
Name [1] 292310 0
.
Address [1] 292310 0
.
Country [1] 292310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294930 0
Melbourne Health HREC
Ethics committee address [1] 294930 0
HREC
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Ethics committee country [1] 294930 0
Australia
Date submitted for ethics approval [1] 294930 0
04/07/2016
Approval date [1] 294930 0
14/10/2016
Ethics approval number [1] 294930 0
RMH HREC QA 2016133

Summary
Brief summary
This study is important in defining the baseline physiological state of patients presenting for outpatient endoscopy. It has been observed that intravenous fluids do not prevent hypotension in patients who are undergoing endoscopy. One possible explanation for this is that patients are not intravascularly deplete after bowel preparation solution. This study will determine what the rate of intravascular depletion in patients undergoing endoscopy after bowel preparation solution is.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65526 0
Dr Megan Allen
Address 65526 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Country 65526 0
Australia
Phone 65526 0
+61 3 9342 7540
Fax 65526 0
Email 65526 0
meganliseallen@gmail.com
Contact person for public queries
Name 65527 0
Dr Megan Allen
Address 65527 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Country 65527 0
Australia
Phone 65527 0
+61 3 9342 7540
Fax 65527 0
Email 65527 0
megan.allen@mh.org.au
Contact person for scientific queries
Name 65528 0
Dr Megan Allen
Address 65528 0
Department of Anaesthesia and Pain Management
Royal Melbourne Hospital
Melbourne, VICTORIA, Australia, 3050
Country 65528 0
Australia
Phone 65528 0
+61 3 9342 7540
Fax 65528 0
Email 65528 0
megan.allen@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in original HREC application
What supporting documents are/will be available?
No other documents available
Summary results
No Results