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Trial registered on ANZCTR


Registration number
ACTRN12616000713493p
Ethics application status
Not yet submitted
Date submitted
4/05/2016
Date registered
30/05/2016
Date last updated
30/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of not fasting prior to coronary angiography and/or percutaneous coronary intervention on the incidence of vomiting and aspiration during the procedure.
Scientific title
Effect of not fasting prior to coronary angiography and/or percutaneous coronary intervention on the incidence of vomiting and aspiration during the procedure.
Secondary ID [1] 289127 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 298606 0
Condition category
Condition code
Cardiovascular 298676 298676 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a cluster randomised, stepped wedge, study. Up to 29,400 patients planned to be enrolled at up to 12 clinical sites in New Zealand. Procedural details will be recorded in the national ANZACSQI registry. Patients in the nonfasted arm (intervention) can have free fluids right up to the procedure and will be recommended to not eat within 2 hours of the procedure and will be supervised by nursing staff prior to the procedure.
Intervention code [1] 294633 0
Prevention
Comparator / control treatment
Standard care peri-procedurally (patients will be fasted - nothing to eat or drink for 6 hours pre-procedure)
Control group
Active

Outcomes
Primary outcome [1] 298169 0
Vomiting, with or without aspiration pneumonitis, which will be assessed by review of procedural records on ANZACS QI
Timepoint [1] 298169 0
From the start of the procedure until the patient leaves the cath lab
Secondary outcome [1] 323354 0
Aspiration (determined by the development of subsequent pneumonitis), which will be assessed by review of procedural records on ANZACS QI
Timepoint [1] 323354 0
From the start of the procedure until the patient leaves the cath lab
Secondary outcome [2] 324168 0
Intubation and Ventilation, which will be assessed by review of procedural records on ANZACS QI
Timepoint [2] 324168 0
From the start of the procedure until the patient leaves the cath lab
Secondary outcome [3] 324169 0
Arrhythmia requiring cardioversion, which will be assessed by review of procedural records on ANZACS QI
Timepoint [3] 324169 0
From the start of the procedure until the patient leaves the cath lab
Secondary outcome [4] 324172 0
Arrhythmia/hypotension requiring CPR, which will be assessed by review of procedural records on ANZACS QI
Timepoint [4] 324172 0
From the start of the procedure until the patient leaves the cath lab
Secondary outcome [5] 324173 0
Hypotension requiring non-protocol mandated intravenous fluids or vasopressor medications, which will be assessed by review of procedural records on ANZACS QI
Timepoint [5] 324173 0
From the start of the procedure until the patient leaves the cath lab
Secondary outcome [6] 324174 0
Systolic blood pressure at time of arterial access, which will be assessed by review of procedural records on ANZACS QI
Timepoint [6] 324174 0
At time of arterial access
Secondary outcome [7] 324175 0
Postponement or previous cancellation of the procedure because patient ate or drank, which will be assessed by review of procedural records on ANZACS QI
Timepoint [7] 324175 0
From the start of the procedure until the patient leaves the cath lab

Eligibility
Key inclusion criteria
All patients undergoing elective or semi-urgent coronary angiography and/ or percutaneous coronary intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treating physician choice
Patients having acute/emergency procedures, such as primary or rescue PCI for STEMI, or angiography for out-of-hospital cardiac arrest

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
A cluster-randomised, stepped-wedge study design will be used, without individual patient consent.
Phase
Type of endpoint/s
Statistical methods / analysis
Number of clusters: 6 large sites, 6 small sites
Number of time periods: 7 time periods, 4 months per period
Number of steps: 6 steps in total, two clusters per step
Randomisation: Two clusters will be randomly allocated to each step, switching from control to intervention phase at scheduled time period (stratified by site size, with 1 large and 1 small site crossed over at each step)
Blinding: Open label

Sample size: A total sample size of 29,400 patients from 12 hospital sites (clusters), with on average 350 patients recruited per time period at each site over 7 study periods of four months (T1-T7), will provide at least 95% power at 2.5% level of significance (one-sided) to detect a non-inferiority margin of 0.6% in the proportion of vomiting with or without aspiration pneumonitis. The control rate was estimated at 0.6% with fasting and the intra-cluster correlation coefficient was set at 0.05.

Statistical analysis: Treatment evaluation will be performed on the principle of intention to treat. The statistical test on the primary outcome will be one-sided at 2.5% level of significance, or two-sided at 5% level. Noninferiority will be evaluated by observing whether the upper bound of the two-sided 95% confidence intervals for the risk difference in vomiting rate between non-fasting and fasting phases was above the noninferiority margin of 0.6%. Generalized linear mixed model will be used to evaluate the intervention effect, with a random effect for cluster and fixed effects for the implementation phase and study time period. The point estimate and 95% confidence interval will be reported using an appropriate link function.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2016
Actual
Date of last participant enrolment
Anticipated
20/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
29400
Accrual to date
Final
Recruitment outside Australia
Country [1] 7849 0
New Zealand
State/province [1] 7849 0

Funding & Sponsors
Funding source category [1] 293496 0
Charities/Societies/Foundations
Name [1] 293496 0
GREEN LANE RESEARCH AND EDUCATIONAL FUND BOARD
Country [1] 293496 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
GREEN LANE RESEARCH AND EDUCATIONAL FUND BOARD
Address
Auckland City Hospital
Cardiology Department
Level 3, Building 32
Park Road
Grafton
AUCKLAND, 1142
Country
New Zealand
Secondary sponsor category [1] 292323 0
None
Name [1] 292323 0
Address [1] 292323 0
Country [1] 292323 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 294939 0
Health and Disability Ethics Committees
Ethics committee address [1] 294939 0
Ethics committee country [1] 294939 0
New Zealand
Date submitted for ethics approval [1] 294939 0
02/06/2016
Approval date [1] 294939 0
Ethics approval number [1] 294939 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65562 0
A/Prof Dr Mark Webster
Address 65562 0
Green Lane Cardiovascular Service,
Auckland City Hospital
Park Rd
Auckland, 1023
New Zealand
Country 65562 0
New Zealand
Phone 65562 0
+64 9 3074949
Fax 65562 0
Email 65562 0
[email protected]
Contact person for public queries
Name 65563 0
Dr Mark Webster
Address 65563 0
Green Lane Cardiovascular Service,
Auckland City Hospital
Park Rd
Auckland, 1023
New Zealand
Country 65563 0
New Zealand
Phone 65563 0
+64 9 3074949
Fax 65563 0
Email 65563 0
[email protected]
Contact person for scientific queries
Name 65564 0
Dr Mark Webster
Address 65564 0
Green Lane Cardiovascular Service,
Auckland City Hospital
Park Rd
Auckland, 1023
New Zealand
Country 65564 0
New Zealand
Phone 65564 0
+64 9 3074949
Fax 65564 0
Email 65564 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.