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Device
Integrated Pulmonary Index for Nurse-administered Procedural Sedation
N/A
Waitlist Available
Led By Aaron Conway, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time between first sedative medication administration to the end of the procedure. estimated duration of procedures is 30 minutes to 120 minutes.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if using capnography with a smart alert system helps nurses better monitor patients' breathing during sedation. It focuses on patients who might have breathing issues while sedated. The system simplifies data to quickly alert nurses when help is needed.
Eligible Conditions
- Nursing
- Conscious Sedation
- Anesthesia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time between first sedative medication administration to the end of the procedure. estimated duration of procedures is 30 minutes to 120 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time between first sedative medication administration to the end of the procedure. estimated duration of procedures is 30 minutes to 120 minutes.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of seconds in an alert condition state from the Medtronic Capnostream 35p monitor without an intervention being applied.
Secondary study objectives
Adverse sedation events
Area under the curve of oxygen desaturation
Duration of alert conditions (defined as the total time that an alert condition was active)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Pulmonary Index enabledExperimental Treatment1 Intervention
Nurses randomized to the experimental arm will be asked to enable the Integrated Pulmonary Index feature of the Medtronic Capnostream 35p monitor when monitoring sedated patients with capnography.
Group II: Integrated Pulmonary Index disabledActive Control1 Intervention
Nurses randomized to the experimental arm will be asked to disable the Integrated Pulmonary Index feature of the Medtronic Capnostream 35p monitor when monitoring sedated patients with capnography.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Integrated Pulmonary Index
2022
N/A
~410
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,527 Previous Clinical Trials
503,145 Total Patients Enrolled
Aaron Conway, PhDPrincipal InvestigatorUniversity of Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Medical procedures will not be done with sedation or monitoring of carbon dioxide levels.
Research Study Groups:
This trial has the following groups:- Group 1: Integrated Pulmonary Index enabled
- Group 2: Integrated Pulmonary Index disabled
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.