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
ACTRN12616001136493
Ethics application status
Approved
Date submitted
18/08/2016
Date registered
19/08/2016
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ventilation status of sedated patients in the cardiac catheterisation laboratory
Scientific title
Ventilation status of sedated patients in the cardiac catheterisation laboratory
Secondary ID [1] 289955 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedation-induced respiratory depression 299941 0
Respiratory 299971 0
Cardiac 299972 0
Condition category
Condition code
Anaesthesiology 299842 299842 0 0
Anaesthetics
Respiratory 299863 299863 0 0
Other respiratory disorders / diseases
Cardiovascular 299864 299864 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Continuous transcutaneous carbon dioxide measurements will be recorded from patients undergoing procedures with conscious sedation, starting before conscious sedation is induced (for measurement of baseline transcutaneous carbon dioxide) and ceasing at the end of the procedure. These measurement will not be available for clinicians monitoring patients (nurses and cardiologists) and will be used purely for analysis.
Intervention code [1] 295644 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299321 0
Transcutaneous carbon dioxide level during sedation (OAA/S level 4 or less) using the Sentec Digital Monitoring System with VSign 2 sensor.
Timepoint [1] 299321 0
Continuous measurements taken every second, which commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure.
Primary outcome [2] 299322 0
Change in transcutaneous carbon dioxide level from baseline whilst sedated (defined as OAA/S 4 or less) using the Sentec Digital Monitoring System with VSign 2 sensor.
Timepoint [2] 299322 0
Continuous measurements taken every second, which commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure
Primary outcome [3] 299323 0
Peak transcutaneous carbon dioxide level whilst sedated (defined as OAA/S 4 or less) using the Sentec Digital Monitoring System with VSign 2 sensor.
Timepoint [3] 299323 0
Continuous measurements taken every second, which commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure
Secondary outcome [1] 326835 0
Incidence of transcutaneous carbon dioxide level >50mmHg whilst sedated (defined as OAA/S 4 or less) using the Sentec Digital Monitoring System with VSign 2 sensor.
Timepoint [1] 326835 0
Continuous measurements taken every second, which commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure.
Secondary outcome [2] 326836 0
Duration of transcutaneous carbon dioxide level >50mmHg whilst sedated (defined as OAA/S 4 or less) using the Sentec Digital Monitoring System with VSign 2 sensor.
Timepoint [2] 326836 0
Continuous measurements taken every second, which commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure.

Eligibility
Key inclusion criteria
Patients undergoing an elective procedure with conscious sedation (intravenous midazolam or midazolam and fentanyl) without an anaesthetist present in a cardiac catheterisation laboratory
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. less than 18 years of age
2. cognitively impaired (due to inability to provide informed consent); or
3. unable to understand and speak English (due to inability to provide written informed consent).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to calculate mean, standard deviation (or median and interquartile range) and 95% confidence intervals of pre-sedation TcCO2 as well as changes in TcCO2 that occur after sedation is administered. Multiple regression will be used to identify associations between ventilation status (measured as the mean tcCO2 whilst OAA/S score 4 or less) and participant and procedural characteristics.
Sample size considerations
A formal sample size calculation is not required for the primary outcome of this study, which is to describe changes in TcCO2 during sedation. It is generally recommended that 10 observations per variable are required for multivariate statistical analysis. We plan to recruit a sample of at least 100 participants in order to examine associations between ten pre-selected variables and post-sedation mean TcCO2 levels. The variables include: age, gender, BMI, sleep apnoea/obesity hypoventilation syndrome status, presence of COPD, smoking status, history of benzodiazepine/opiod use, total dose of opioids and total dose of midazolam, supplemental oxygen use and clinician interventions to support ventilation (realigning airway, verbal/physical stimulation to increase level of consciousness).

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)
QLD
Recruitment hospital [1] 6496 0
John Flynn - Gold Coast Private Hospital - Tugun
Recruitment hospital [2] 7201 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 14060 0
4224 - Tugun
Recruitment postcode(s) [2] 14964 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 294334 0
University
Name [1] 294334 0
QUT School of Nursing Seeding Grant
Address [1] 294334 0
QUT
60 Musk Ave
Kelvin Grove QLD 4059
Country [1] 294334 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 293171 0
None
Name [1] 293171 0
Address [1] 293171 0
Country [1] 293171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295754 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 295754 0
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Ethics committee country [1] 295754 0
Australia
Date submitted for ethics approval [1] 295754 0
Approval date [1] 295754 0
14/06/2016
Ethics approval number [1] 295754 0
16/35

Summary
Brief summary
Respiratory depression is more likely to be detected during sedation when capnography is used. However, sedation-induced respiratory depression is commonly transient and does not always cause patient harm. Randomised controlled trials have produced conflicting results regarding whether capnography improves patient safety when used during sedation. Further research is required to determine whether applying capnography to the conscious sedation context is warranted. One considerable difficulty in designing a trial to determine whether a specific intervention improves the safety of conscious sedation is that adverse sedation events that pose potential risks to patient safety, such as hypoxaemia, should be so rare that it would not be feasible to recruit the required number of participants. In contrast, the number of participants required to detect a clinically significant difference in ventilation status during conscious sedation, as measured by transcutaneous carbon dioxide concentration (TcCO2), would be feasible to recruit in the context of a clinical trial. However, in order to calculate a sample size for such a trial, the expected control group TcCO2 needs to be identified. In this study, continuous TcCO2 measurements will be recorded from patients undergoing procedures with conscious sedation, starting before conscious sedation is induced (for measurement of baseline TcC02) and ceasing at the end of the procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68338 0
Dr Aaron Conway
Address 68338 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 68338 0
Australia
Phone 68338 0
+61731386124
Fax 68338 0
Email 68338 0
aaron.conway@qut.edu.au
Contact person for public queries
Name 68339 0
Dr Aaron Conway
Address 68339 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 68339 0
Australia
Phone 68339 0
+61731386124
Fax 68339 0
Email 68339 0
aaron.conway@qut.edu.au
Contact person for scientific queries
Name 68340 0
Dr Aaron Conway
Address 68340 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 68340 0
Australia
Phone 68340 0
+61731386124
Fax 68340 0
Email 68340 0
aaron.conway@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results