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Ventilation status of sedated patients in the cardiac catheterisation laboratory

Ventilation status of sedated patients in the cardiac catheterisation laboratory

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001136493
Enrollment
78
Registered
2016-08-19
Start date
2016-08-17
Completion date
2018-06-15
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026