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Respiratory DepressionVIGILANCENCT02907255

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

A study testing Oximetry monitor in people with Respiratory Depression, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Depression
What is being tested?
Oximetry monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,512 participants
Where
1 siteCanada
Study dates
Oct 2010to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patient's refusal to be monitored

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Hamilton Health Sciences-Juravinski Hospital Location

    Hamilton, Ontario, L8V 1C3

Other trials in Canada

About this study

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.

Read the detailed description

Patients are at risk for respiratory depression in the perioperative period. The opioids used in both patient controlled analgesia (PCA) and epidural analgesia can cause respiratory depression. The progression of opioid side effects usually starts with sedation, respiratory depression follows and, if left uncorrected, this can lead to respiratory and then cardiac arrest and death. Sedation is a common side-effect, occurring in about 13% of patients and the incidence of respiratory depression varies depending on the precise definition used and the analgesia modality, but it has been reported to occur in about 1% of cases. If you continuously monitor patients with oximetry and capnography the incidence of respiratory depression has been shown to be much higher, as high as 12%8. The incidence of cardiac arrest and death from opioid overdose has been estimated at about 2 cases per 10, 0009. Given that the number of patients undergoing surgery annually is about 100 million worldwide, respiratory depression occurs between 1 and 12 million times and it results in about 20, 000 preventable deaths each year10. The troublesome aspect of this complication is that it often occurs in healthy patients where the family and clinical staff do not anticipate a bad outcome.

The problem of unexpected respiratory depression amongst patients treated with opioids is compounded by the challenge of dealing with obstructive sleep apnea patients in the perioperative period. Obstructive sleep apnea, characterized by the complete or partial obstruction of the upper airway during sleep, is not rare, with about 25% of the general population (and a greater proportion of the surgical population) being at risk for this condition. These patients are at even greater risk of perioperative respiratory events and consequently the guidelines from the American Society of Anesthesiology recommend continuous monitoring of these patients13,14. These guidelines are expert-based as no clinical trials have established the efficacy of continuous monitoring in this population.

These two problems (respiratory depression from opioids and obstructive sleep apnea) have caused significant logistic problems in hospitals as many institutions do not have the equipment to provide continuous monitoring of patients outside of the intensive care units and there is limited capacity in the critical care areas to monitor all the patients at risk.

The impact of respiratory depression can be mitigated if it is recognized early enough and appropriate actions are taken to resuscitate the patient. Early recognition of this complication depends on frequent and regular vital sign assessments by nursing staff.

he problem in many surgical wards is that nursing staff, particularly at night, are spread thin and patients can occasionally go several hours without being seen. In this a period a patient can spiral into trouble from sedation to respiratory depression and eventually into respiratory and cardiac arrest. Previously, cardiac monitoring with telemetry has been available and could be used for patients in the perioperative period. Although telemetry has been proven useful for some groups of patients (including those with an automated defibrillator that has fired, those with a prolonged QT interval and those with acute heart failure) this technology will only pick up cases of respiratory depression that progress into a cardiac event15.

Recently technology has become commercially available to continuously monitor pulse oximetry and notify clinical staff wirelessly via a paging system. The advantage of such a system is that clinicians can be notified immediately when a patient begins to decompensate from respiratory depression within enough time to initiate resuscitation before the patient progresses to respiratory or cardiac arrest. Another benefit of these systems is that patients at risk can be monitored on regular surgical wards without utilizing additional nursing staff. A recent literature search (of MEDLINE) that searched the concepts of respiratory monitoring in the perioperative period (using the MESH keywords: monitoring, oximetry, postoperative period and clinical trial) was conducted to see if there was evidence to support the use of these systems. Only a single study was identified in the search that specifically investigated the postoperative period, a before-after study on a 36-bed orthopedic ward found that a respiratory monitoring system was effective in reducing the need for rescue resuscitations and ICU transfers16. Although there is a Cochrane review on pulse oximetry for perioperative monitoring, this study focused only on intraoperative and recovery room monitoring and did not address monitoring of patients while on surgical wards17.

Given these promising results, a respiratory monitoring will be trialed on two surgical wards at the Juravinski Hospital in Hamilton, Ontario. In order to evaluate the impact of this technology the investigators designed a randomized controlled trial to determine if routine wireless respiratory monitoring for 72 hours of surgical patients on two surgical wards (that care for general surgery, urology and gynecology-oncology patients) reduces the need for rescue resuscitations - Naloxone resuscitation of opioid overdose, Code Blues (Cardio-respiratory arrests) and Intensive Care Unit (ICU) transfers. In addition, this study will also evaluate the risk factors for respiratory depression, the types and duration of respiratory alarms that occur and the impact on nursing workflow.

Being tested
Oximetry monitor
Keywords
Pulse oximetry, vital signs monitoring, wireless notification of clinicians, respiratory monitoring system
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oximetry monitorDevice

    Also called Covidien Nellcor Oxinet II

    Wireless respiratory monitoring system

Study groups in NCT02907255
Study groupRoleWhat they receive
Oximetry monitorExperimental* Standard care plus * Wireless respiratory monitoring * Covidien * Alarm triggers: SpO2 ≤89% (heart rate) HR < 50 or > 120
Receives: Device: Oximetry monitor
Standard of CareNo 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 days

Secondary outcomes (6)
  1. Risks factors for alarm events

    Baseline patient information on all patients admitted to the study wards will be recorded including their demographics, past medical history and surgical details. Cases of respiratory depression will be flagged by the monitoring system and a regression analysis will be used to determine the risk factors for respiratory events.

    Measured: 3 days

  2. Monitor acceptance rate by patients

    Number of patients who accept or refuse to use the monitor will be recorded

    Measured: 3 days

  3. Number of alarms per patient per day

    Alarm details will be downloaded from the servers for the respiratory monitoring systems. Alarm types and duration and questionnaire results will be described with descriptive statistics.

    Measured: 3 days

  4. Type (true or false alarms) and duration of alarms

    Alarm details will be downloaded from the servers for the respiratory monitoring systems. Alarm types (true or false) and duration and questionnaire results will be described with descriptive statistics.

    Measured: 3 days

  5. Response to alarm by nursing staff

    The impact the monitoring system has on nursing workflow will be quantified by a study questionnaire and by a workflow assessment tool developed by Cornell et al.18. This behavioral-based list of 29 activities, that are mutually exclusive and comprehensive, will be modified to include items for responding to and documenting the respiratory alarms. Questionnaire results will be described with descriptive statistics. All nursing staff will fill out the questionnaire at the end of the study and the alarm documentation form will be filled out by each nurse that responds to a system alarm.

    Measured: 3 days

  6. Impact on nursing workflow

    The impact on nursing workflow will be assessed with a questionnaire which assesses their subjective feedback regarding the reliability of the system, its ease of use and its impact on patient safety. The nurse's responses to the alarms will be determined with an 'Alarm/Event Documentation Form' that is filled out by the bedside nurse. - questionnaire results will be described with descriptive statistics. All nursing staff will fill out the questionnaire at the end of the study and the alarm documentation form will be filled out by each nurse that responds to a system alarm.

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startOct 2010
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907255
Sponsor's protocol ID
10-581
Acronym
VIGILANCE
Status last verified
Aug 2026
First submitted
7 Sep 2016
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18945716
  • 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.

    PubMed 16738293
  • 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.

    PubMed 20098128
  • 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.

    PubMed 31661079
  • 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.

    PubMed 30858986

Questions about this trial

What is this clinical trial studying?

A study testing Oximetry monitor in people with Respiratory Depression, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of rescue respiratory resuscitations and ICU Transfers (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907255, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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