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Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory

Optimising the clinical application of capnography for monitoring ventilation of sedated patients in the cardiac catheterisation laboratory

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001132437
Enrollment
114
Registered
2016-08-19
Start date
2016-08-15
Completion date
2018-05-14
Last updated
2020-01-13

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 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.

Interventions

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 measurement

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.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

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

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