Integrated Pulmonary Index for Nurse-administered Procedural Sedation

NCT05068700 | Completed

• 1 other identifier: CAPCR-21-5249.0
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief 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.)

Conditions

Conscious Sedation; Nursing; Anaesthesia

Keywords

capnography; sedation

Outcome Measures

Primary Outcomes (1)

• Number of seconds in an alert condition state from the Medtronic Capnostream 35p monitor without an intervention being applied.

  Continuous capnography measurements will be recorded using the Medtronic Capnostream 35p monitor.

  From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

Secondary Outcomes (6)

• Total number of Medtronic Capnostream 35p monitor alarms

  From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

• Number of appropriate alarms (defined as an alarm that triggered an intervention

  From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

• Number of inappropriate alarms (defined as alarms that were triggered but manually dismissed by silencing the alarm)

  From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

• Duration of alert conditions (defined as the total time that an alert condition was active)

  From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

• Adverse sedation events

  From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

Study Arms (2)

Integrated Pulmonary Index disabled

ACTIVE COMPARATOR

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.

Device: Standard capnography monitoring

Integrated Pulmonary Index enabled

EXPERIMENTAL

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.

Device: Integrated Pulmonary Index

Interventions

Integrated Pulmonary Index DEVICE

Medtronic Capnostream 35p monitoring parameter

Integrated Pulmonary Index enabled

Standard capnography monitoring DEVICE

Medtronic Capnostream 35p monitoring parameter

Integrated Pulmonary Index disabled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Procedures performed without sedation or capnogrpahy monitoring

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Canada

Location

Related Publications (2)

• Conway A, Goudarzi Rad M, Chang K, Parotto M, Mafeld S. Integrated pulmonary index during procedural sedation and analgesia: A cluster-randomized trial. J Adv Nurs. 2025 Sep;81(9):5563-5572. doi: 10.1111/jan.16286. Epub 2024 Jun 26.

  PMID: 38924169 DERIVED

• Conway A, Chang K, Goudarzi Rad M, Mafeld S, Parotto M. Integrated Pulmonary Index during nurse-administered procedural sedation: Study protocol for a cluster-randomized trial. J Adv Nurs. 2022 Jul;78(7):2245-2254. doi: 10.1111/jan.15243. Epub 2022 Apr 29.

  PMID: 35485238 DERIVED

Study Officials

• Aaron Conway, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a cluster-randomized trial. 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.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 6, 2021
• Study Start: April 22, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: With publication of results
• Access Criteria: Available through a public repository

Locations

CA (1)