Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05068700 |
| Other study ID # |
CAPCR-21-5249.0 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2022 |
| Est. completion date |
June 15, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
University Health Network, Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Implementing capnography into practice for respiratory monitoring during sedation is
considered a high priority by leading authorities in Canada and internationally. The Canadian
Anesthesiologists' Society's position statement recommends that capnography should be
available wherever moderate or deep sedation is used. The Academy of Medical Royal Colleges
(UK) Standard and Guidance report on Safe Sedation Practice for Healthcare Procedures noted
that while capnography is not a mandated practice, providers should consider implementing
capnography as a long term goal. These recommendations are in place because sedated patients
who are not monitored with capnography have frequent undetected, and therefore untreated,
respiratory depression. Of note, though, these guidelines do not provide specific
recommendations for how capnography should be implemented for nurse-administered sedation.
The aim of this study is to determine if smart alarm guided treatment of respiratory
depression using the Integrated Pulmonary Index is an effective way to implement capnography
during nurse-administered sedation. The primary outcome is the number of seconds in an alert
condition state without an intervention being applied. The IPI is intended to reduce the
cognitive burden of synthesizing multiple sources of physiological monitoring input and hence
lowering the threshold for triggering intervention by clinicians to support respiration. The
primary outcome directly measures this concept by quantifying the time taken for an alert to
trigger an intervention.
Higher values of the primary outcome will result from either a problem state that should have
triggered an intervention but did not, or an 'inappropriate' alert (i.e. an alert that was
not important enough to warrant immediate intervention.)
Description:
A hybrid effectiveness-implementation design will be used for this study, incorporating a
parallel cluster randomized trial. Capnography monitoring will be implemented as standard
practice for all patients undergoing procedures with nurse-administered sedation in the four
departments participating in the study, as per recommendations for procedural sedation in
Canada. Nurses working in the four departments will be invited to choose to participate in
the randomized controlled trial component of the study. If they choose to participate, they
will be randomized to use capnography either with or without the Integrated Pulmonary Index
(IPI) enabled.
There will be establishment and stability phases where the implementation of capnography
(with or without IPI enabled) into practice commences and is optimized through an audit and
feedback process. Data collection for the primary outcome will be undertaken during the
evaluation period. This design was chosen for two main reasons. First, it allows for the
establishment phase, which will provide the time required for the research team to
meaningfully engage with staff at each department and recruit nurses to participate in the
randomized controlled trial component of the study. Second, the stability period will involve
sustained engagement with clinicians in the department, regardless of assignment, in order to
optimize the implementation of capnography monitoring (with or without the IPI enabled) into
practice using a facilitated audit and feedback process.
Sedation management and monitoring
Medication
There will be no restrictions on sedation dosing for this study. It is typical for a bolus
dose of 25-50mcg of fentanyl followed by 1-2mg of midazolam to be administered approximately
two to five minutes prior to procedure commencement. Further doses of 1mg midazolam and 25mcg
fentanyl are usually administered at the discretion of the proceduralist to maintain
sedation.
Supplemental oxygen
Supplemental oxygen is routinely applied for patients unless contraindicated by pre-existing
conditions, such as severe chronic obstructive pulmonary disease. The oxygen flow rate will
be adjusted as per direction from the proceduralist.
Physiological monitoring
As part of usual practice in these departments, all patients receive all aspects of standard
physiological monitoring including electrocardiography for heart rate and rhythm,
non-invasive blood pressure measurements taken at regular 5-10 minute intervals (or more
frequently if deemed required by nursing or medical staff) and continuous pulse oximetry.
Assessments of respiratory rate and depth, as well as level of consciousness, are taken at
regular intervals.
Additionally in this study, the standalone Capnostream 35p monitor (Medtronic) will be used.
It displays a capnography waveform as well as end-tidal CO2 and respiratory rate. A nasal
cannula or facemask that allows oral and nasal sampling of exhaled air as well as the
delivery of supplemental oxygen will be used (Medtronic). The nasal cannula or facemask will
be connected to the capnography monitoring device (Capnostream 35P, Medtronic). Nurses who
choose to participate in the randomized controlled trial component of this hybrid
effectiveness-implementation study, will be randomized to use capnography with or without the
Integrated Pulmonary Index enabled. The IPI is a feature, which can be enabled in the
Capnostream 35p devices. Nurses who are *not* participating in the randomized controlled
trial component of the study will use capnography with or without the IPI feature enabled, at
their own discretion. The Capnostream 35p monitor also collects SpO2 and heart rate
measurements via pulse oximetry using a finger probe.
Establishment period
The establishment and stability periods will be guided by recommendations for improving the
quality of clinical alarms from The Society for Critical Care Medicine Alarm and Alert
Fatigue Task Force.
During the establishment period, each department will be provided with 2 Capnostream 35p
monitors so that capnography monitoring can become part of routine practice for
nurse-administered sedation. At this time, the research team will assist with providing
education to nursing staff for capnography monitoring and the Integrated Pulmonary Index. The
principal investigator will provide an overview of the Capnostream 35p device and how to use
it, including the functionality of the Integrated Pulmonary Index. All nursing staff will be
provided with printed information about how to access a standardized education program
designed by Medtronic, which is certified for accreditation with the American Nurses
Credentialing Centre and American Association for Respiratory Care
(https://www.medtronic.com/covidien/en-us/clinical-education/catalog/healthstream-capnography
-standard-of-care-for-procedural-sedation-monitoring.html). Specifically, in this course
nurses will have access to education material covering topics including how to detect common
capnographic waveform abnormalities, which indicate sedation-induced alveolar
hypoventilation, and implement an appropriate intervention if indicated according to the
alert conditions.
Stability period
The goal of the stability period is to optimize the alarm conditions set for the Capnostream
35p devices prior to the evaluation period. We will undertake an audit and feedback process
for nurses choosing to participate in the randomized controlled trial component of the study.
The audit and feedback process will evaluate the performance characteristics of the alerts
triggered by the Capnostream 35p monitor (with or without IPI enabled depending on
randomization). Alert performance characteristics to be audited include:
- Alarm burden (total number of alarms triggered by the Capnostream 35p).
- Number of appropriate alarms (defined as an alarm that triggered an intervention).
- Number of inappropriate alarms (defined as alarms that were triggered but manually
dismissed by silencing the alarm).
- Duration of alert conditions (defined as the total time that an alert condition was
active).
The Research Assistant will need to be present during procedures to observe and record the
type of interventions implemented in response to capnography monitor alarms, as well as the
time that the intervention was observed. A web-based data collection tool has been designed
for this purpose (more detail is provided in the data collection section below).
The feedback of data collected during the audits for nurses who choose to participate in the
randomized controlled trial will take an aggregated summary form per department. It will
further delineate alarm performance characteristics depending on whether or not the IPI was
enabled. The feedback will be presented on a webpage created for each department so that it
can be updated approximately weekly as new audits are performed. The link to the webpage will
be provided to nurses at the time of randomization. Access to the webpage will be restricted
to users through an email address with an organizational domain (i.e. uhn.ca). The webpage
will contain tabulated and other visual summaries of the audit data to highlight alarm
performance characteristics, such as the number and duration of appropriate and inappropriate
alarms, total alarms etc. In addition to the webpage, the Principal Investigator and/or
Research Assistant will present summary findings from the audits at departmental meetings at
least once per month to facilitate discussion amongst staff as to the appropriateness of
current alarm settings and if changes are indicated.
The alarm conditions set for the Capnostream 35p monitor can be revised at any time
throughout the study period at the discretion of the nurses based on insights from this audit
of performance characteristics. This is an implementation study, employing an audit and
feedback process to assist departmental staff to optimize capnography alarm settings (with or
without the IPI enabled).
Evaluation period
Alarm performance for the Capnostream 35p monitor, now optimized for each capnography
monitoring condition through the establishment and stability periods, will be compared
between nurses randomized to use capnography alone or with the Integrated Pulmonary Index
enabled.
Procedures
Participant selection and enrollment
Due to the hybrid effectiveness-implementation design to be used, all patients undergoing
procedures in the departments included in this study will receive capnography monitoring. We
anticipate that approximately 1200 patients will undergo procedures with capnography
monitoring across the departments during the study overall. The target sample size for the
evaluation period is 400 patient participants (sample size calculation presented in a section
below).
This study involves only routinely collected clinical data and direct observation of nursing
responses to capnography monitor alarms. As such, consent from patients will not be sought.
The Tri-Council Policy Statement requires a study to fulfill conditions for waiver of
consent, including that the alteration to consent requirement is necessary to address the
research question. The integration of capnography monitoring with or without the IPI enabled
is planned to be optimized in this implementation study through an audit and feedback
process. As such, it will be impossible for individual patients to provide consent for
participation in this study prior to the initiation of implementation and optimization of
capnography into nurses routine care of sedated patients. In the 'evaluation' period
specifically, a Research Assistant will observe procedures being performed with nurses who
have chosen to participate in the randomized controlled trial component of the study on
randomly selected days of the week until the target sample size is reached. The Research
Assistant will be blinded to allocation status, as this is essential for studies that use
clustered randomized trial designs to reduce risk of selection bias.
Data collection
This study involves only routinely collected clinical data and direct observation of nursing
responses to capnography monitor alarms. During all phases ('establishment', 'stability' and
'evaluation'), we will retrospectively retrieve data recorded on the Capnostream 35p monitors
using the USB port. Specifically, the 'Real-time Full Continuous Transfer' report will be
downloaded. This report contains the real-time CO2 waveform plus real-time values of
parameters (EtCO2, SpO2, pulse rate, respiratory rate, and IPI) with 1-second resolution by
repeating numerical values for every 50ms along with the waveform. Other fields include the
patient type (adult), report generation date and time, alarm occurrences, equipment advisory
messages (eg. waveform not available, battery low, etc) and events entered into the monitor
by a clinician (medication administrations etc).
During the 'stability' and 'evaluation' periods, a Research Assistant will be present during
procedures to observe and record the type of interventions used, as well as the time that it
was observed. A web-based data collection tool has been designed for this purpose, which will
be accessed using an iPad. The times will be synced with the capnography monitoring device
(Capnostream 35p).
During the 'stability and 'evaluation' periods, standard demographic and clinical
characteristics will be collected by a Research Assistant. Procedural characteristics (type
and duration) and sedation characteristics (medication type and dosages) will be collected
for the purposes of the audit and feedback process in the 'stability' periods and for the
purposes of describing the participant characteristics in the evaluation period.
