ANZCTR - Registration

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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

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]

None known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

sedation-induced respiratory depression

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

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]

Treatment: Devices

Comparator / control treatment

No control

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

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]

*Primary outcome: Duration in seconds of apnoea (defined as absence of capnography waveform) whilst sedated (defined as OAA/S 4 or less)

Timepoint [1]

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]

*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]

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]

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]

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]

Disability-free survival (measured with the World Health Organization Disability Assessment Schedule 2.0)

Timepoint [4]

30 days post-procedure

Secondary outcome [5]

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]

30 days post-procedure

Secondary outcome [6]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/08/2016

Date of last participant enrolment

Anticipated

Actual

14/05/2018

Date of last data collection

Anticipated

Actual

14/06/2018

Sample size

Target

200

Accrual to date

Final

114

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Wesley Hospital - Auchenflower

Recruitment hospital [2]

Holy Spirit Northside - Chermside

Recruitment postcode(s) [1]

4066 - Auchenflower

Recruitment postcode(s) [2]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Wesley Medical Research

Address [1]

451 Coronation Drive
Auchenflower QLD 4066

Country [1]

Australia

Primary sponsor type

University

Name

Queensland University of Technology

Address

60 Musk Ave
Kelvin Grove QLD 4059

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UnitingCare Health Human Research Ethics Committee

Ethics committee address [1]

451 Coronation Drive
Auchenflower QLD 4066

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/06/2016

Ethics approval number [1]

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

Dr Aaron Conway

Address

Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059

Country

Australia

Phone

+61731386124

Fax

aaron.conway@qut.edu.au

Contact person for public queries

Name

Aaron Conway

Address

Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059

Country

Australia

Phone

+61731386124

Fax

aaron.conway@qut.edu.au

Contact person for scientific queries

Name

Aaron Conway

Address

Institute of Health and Biomedical Innovation
Queensland University of Technology
60 Musk Ave
Kelvin Grove QLD 4059

Country

Australia

Phone

+61731386124

Fax

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?

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

Source	Title	Year of Publication	DOI
Embase	Pre-apneic capnography waveform abnormalities during procedural sedation and analgesia.	2020	https://dx.doi.org/10.1007/s10877-019-00391-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically