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Trial registered on ANZCTR


Registration number
ACTRN12616001132437
Ethics application status
Approved
Date submitted
16/08/2016
Date registered
19/08/2016
Date last updated
20/02/2019
Date data sharing statement initially provided
20/02/2019
Date results information initially provided
20/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory
Scientific title
Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory
Secondary ID [1] 289937 0
None known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedation-induced respiratory depression 299920 0
Condition category
Condition code
Anaesthesiology 299814 299814 0 0
Anaesthetics
Respiratory 299871 299871 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alterations in capnography waveforms and end-tidal carbon dioxide levels observed during procedures performed in a cardiac catheterisation laboratory with nurse-administered sedation (midazolam or midazolam plus fentanyl) will be used to measure the incidence and duration of episodes of sedation-induced respiratory depression (e.g. hypoventilation and apnoea). Capnography waveforms and end-tidal carbon dioxide levels will be measured from the start to the end of the procedures. These measurements are available to the clinicians (nurses and cardiologists) monitoring patients during procedures and as such may influence treatment decisions.
Intervention code [1] 295619 0
Treatment: Devices
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299290 0
Duration in seconds of hypoventilation caused by partial airway obstruction (defined as a decrease in ETCO2 levels of >10% from baseline that improves with airway repositioning) whilst sedated (defined as OAA/S 4 or less);
Timepoint [1] 299290 0
Continuous measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure
Primary outcome [2] 299319 0
Duration in seconds of hypoventilation caused by reduced tidal volume respiration (defined as a decrease in ETCO2 levels of >10% from baseline that does not improve with airway repositioning or an increase in ETCO2 levels of >10% from baseline) whilst sedated (defined as OAA/S 4 or less)
Timepoint [2] 299319 0
Continuous capnography measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure
Primary outcome [3] 299320 0
Duration in seconds of bradypnoeic hypoventilation (defined as respiratory rate of less than 10 breaths per minute) whilst sedated (defined as OAA/S 4 or less)
Timepoint [3] 299320 0
Continuous capnography measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure
Secondary outcome [1] 326829 0
*Primary outcome: Duration in seconds of apnoea (defined as absence of capnography waveform) whilst sedated (defined as OAA/S 4 or less)
Timepoint [1] 326829 0
Continuous capnography measurements taken every second commence approximately 5 minutes prior to the start of the procedure and are ceased at the end of the procedure
Secondary outcome [2] 326830 0
*Primary outcome: Duration in seconds of hypoxaemia throughout the procedure (defined as percentage of haemoglobin that is saturated with oxygen [SpO2] is less than 90%)whilst sedated (defined as OAA/S 4 or less)
Timepoint [2] 326830 0
Continuous SpO2 measurements taken every second commence approximately 10 minutes prior to the start of the procedure and are ceased at the end of the procedure
Secondary outcome [3] 326831 0
Mean 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] 326831 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 [4] 326832 0
Disability-free survival (measured with the World Health Organization Disability Assessment Schedule 2.0)
Timepoint [4] 326832 0
30 days post-procedure
Secondary outcome [5] 326833 0
Post-operative pulmonary complications (from a medical chart review), defined as: a. Respiratory infection that required treatment with antibiotics; b. Pleural effusion confirmed by chest radiograph radiologist report; c. Atelectasis confirmed by chest radiograph radiologist report; c. Pneumothorax confirmed by chest radiograph radiologist report; d. Bronchospasm (newly detected expiratory wheezing treated with bronchodilators); e. Aspiration pneumonitis (Respiratory failure after the inhalation of regurgitated
gastric contents).
Timepoint [5] 326833 0
30 days post-procedure
Secondary outcome [6] 326834 0
Cardiovascular complications (from medical chart review) defined as i. Cardiac arrest (defined as ventricular fibrillation, asystole, electromechanical dissociation or ventricular tachycardia without cardiac output that required cardiopulmonary resuscitation and cardioversion); or ii. Myocardial infarction (defined as confirmed myocardial infarction distinct from index event)
Timepoint [6] 326834 0
30 days post-procedure

Eligibility
Key inclusion criteria
Patients undergoing an elective procedure with moderate 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 of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
The primary aim of this study is to identify subgroups of patients based on their physiological responses to sedation (i.e. hypoventilation and apneas). We initially planned to use a statistical analysis procedure called Latent Class Analysis (LCA) to identify the subgroups and our sample size calculation indicated that 180 participants was recommended for LCA models with 5 indicators, assuming power of 0.8 and a medium effect size (0.3). A sample that is too small may lead to choosing a solution from LCA where the number of classes (subgroups) does not adequately describe the data. To address this risk, we used a different statistical analysis procedure to achieve the primary aim of the study, known as ‘Sequence Analysis’ (approved by the HREC). State sequence analysis is a model-free data-driven approach to the analysis of succession of states, which is commonly used for the analysis of longitudinal data.

Recruitment
Recruitment status
Completed
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] 6487 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 7242 0
Holy Spirit Northside - Chermside
Recruitment postcode(s) [1] 15009 0
4032 - Chermside
Recruitment postcode(s) [2] 14050 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 294315 0
Charities/Societies/Foundations
Name [1] 294315 0
Wesley Medical Research
Address [1] 294315 0
451 Coronation Drive
Auchenflower QLD 4066
Country [1] 294315 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Ave
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 293154 0
None
Name [1] 293154 0
Address [1] 293154 0
Country [1] 293154 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295740 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 295740 0
451 Coronation Drive
Auchenflower QLD 4066
Ethics committee country [1] 295740 0
Australia
Date submitted for ethics approval [1] 295740 0
Approval date [1] 295740 0
17/06/2016
Ethics approval number [1] 295740 0
1614

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 and there is considerable variation in the utilisation of capnography monitoring in clinical practice. This project seeks to optimise the implementation of this technology into clinical practice.
AIMS
1. To identify subgroups of patients based on their physiological responses to sedation.
2. To characterise the identified subgroups by determining whether they are associated with particular demographic and clinical characteristics.
3. To examine variation in clinical interventions applied to support respiratory function between subgroups.
4. To determine if there are associations between the subgroups and intra-procedural ventilation status as well as post-procedural outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68274 0
Dr Aaron Conway
Address 68274 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 68274 0
Australia
Phone 68274 0
+61731386124
Fax 68274 0
Email 68274 0
aaron.conway@qut.edu.au
Contact person for public queries
Name 68275 0
Dr Aaron Conway
Address 68275 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 68275 0
Australia
Phone 68275 0
+61731386124
Fax 68275 0
Email 68275 0
aaron.conway@qut.edu.au
Contact person for scientific queries
Name 68276 0
Dr Aaron Conway
Address 68276 0
Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059
Country 68276 0
Australia
Phone 68276 0
+61731386124
Fax 68276 0
Email 68276 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
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary