Vital Sign Monitoring With Continuous Pulse Oximetry and Wireless Clinician Notification After Surgery

NCT02907255 | Completed

• 1 other identifier: 10-581
• Study Type: interventional
• Target: 2,512
• Locations: 1 country
• Sites: 1

Brief Summary

Patients are at risk of respiratory depression after having surgery. The medications that patients are treated with to control their pain can impair their breathing and this can progress to respiratory and cardiac arrest and even death. Vital signs assessment on surgical wards is usually done every 4 hours and this may be insufficient to identify and manage many cases of respiratory depression. The aim of this study is to determine the impact on safety and nursing workflow of a respiratory monitoring on two surgical wards by measuring safety outcomes. Respiratory depression is a serious complication of pain treatment that can lead to patient complications and death. The level of monitoring available in hospitals by nursing staff is insufficient to manage this problem. If this new monitoring technology works as designed then patient safety can be improved while maintaining effective pain therapy.

Conditions

Respiratory Depression

Keywords

Pulse oximetry; vital signs monitoring; wireless notification of clinicians; respiratory monitoring system

Outcome Measures

Primary Outcomes (1)

• Incidence of rescue respiratory resuscitations and ICU Transfers

  Incidence of respiratory resuscitations and ICU transfers will be displayed as box plots and expressed as an odds ratio with 95% confidence intervals. The primary outcome (respiratory resuscitations) will be collected through the existing hospital administrative systems: the Acute Pain Service records, Naloxone administration for respiratory depression and the Department of Critical Care records all Code Blues and ICU transfers.

  3 days

Secondary Outcomes (6)

• Risks factors for alarm events

  3 days

• Monitor acceptance rate by patients

  3 days

• Number of alarms per patient per day

  3 days

• Type (true or false alarms) and duration of alarms

  3 days

• Response to alarm by nursing staff

  3 days

Study Arms (2)

Oximetry monitor

EXPERIMENTAL

* Standard care plus * Wireless respiratory monitoring * Covidien * Alarm triggers: SpO2 ≤89% (heart rate) HR \< 50 or \> 120

Device: Oximetry monitor

Standard of Care

NO INTERVENTION

• Standard care: * 1:4 patient to nurse ratio * Vital signs every 4 hours * Respiratory rate and sedation scores every 2 hours for patients on the Acute Pain Service

Interventions

Oximetry monitor DEVICE

Wireless respiratory monitoring system

Also known as: Covidien Nellcor Oxinet II

Oximetry monitor

Eligibility Criteria

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

You may qualify if:

• All surgical admission to wards E4 and F4 at Juravinski Hospital in Hamilton, Ontario, Canada

You may not qualify if:

• Patient's refusal to be monitored

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton Health Sciences-Juravinski Hospital Location

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (5)

• Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.

  PMID: 18945716 BACKGROUND

• Syed S, Paul JE, Hueftlein M, Kampf M, McLean RF. Morphine overdose from error propagation on an acute pain service. Can J Anaesth. 2006 Jun;53(6):586-90. doi: 10.1007/BF03021849.

  PMID: 16738293 BACKGROUND

• Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b.

  PMID: 20098128 BACKGROUND

• Harsha P, Paul JE, Chong MA, Buckley N, Tidy A, Clarke A, Buckley D, Sirko Z, Vanniyasingam T, Walsh J, McGillion M, Thabane L. Challenges With Continuous Pulse Oximetry Monitoring and Wireless Clinician Notification Systems After Surgery: Reactive Analysis of a Randomized Controlled Trial. JMIR Med Inform. 2019 Oct 28;7(4):e14603. doi: 10.2196/14603.

  PMID: 31661079 DERIVED

• Paul JE, Chong MA, Buckley N, Harsha P, Shanthanna H, Tidy A, Buckley D, Clarke A, Young C, Wong T, Vanniyasingam T, Thabane L. Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)-a randomized controlled pilot trial. Pilot Feasibility Stud. 2019 Feb 26;5:36. doi: 10.1186/s40814-019-0415-8. eCollection 2019.

  PMID: 30858986 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• James E Paul, MD

  Associate Clinical Professor, Research Chair & Director of Acute Pain Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 20, 2016
• Study Start: October 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 28, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)