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Completed

NCT Number: NCT03043911

Improved Patient Safety Through Continuous Bi-channel RR and SpO2 Monitoring With Masimo Patient SafetyNet

The investigator intend to perform an observational study, by adding Respiratory Rate monitoring to an already existing Patient SafetyNet system with SpO2 (Oxygen Saturation) and PR (Pulse Rate) monitoring. RRa will be blinded to the clinicians and all RRa alarms will be deactivated. Retrospective analysis of the observational data collected will be utilized to evaluate the potential benefits of additional continuous respiratory rate monitoring.

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Key information

Conditions

Signs and Symptoms, Respiratory Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

About this study

Addition of acoustic respiratory rate monitoring to an already existing standard of care patient surveillance system that includes oxygen saturation and heart rate monitoring by pulse oximetry will result in earlier and more sensitive detection of respiratory events and possibly early stages of developing sepsis in a post-surgical/orthopedic study population.

An observational study with RRa is an additional blinded parameter to the already existing standard of care monitoring with SpO2 and PR on one post-surgical floor, (includes Trauma and orthopedic patients), where patients receive opioids for pain management. 300 consecutive patients will be enrolled and monitored with RRa for at least the first 24hours post-surgery, after discharge from the Recovery Room, & upon admission to the Surgical floor.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Adult 18yrs of age or older
  • Post-surgical patient receiving opioid pain medication

Exclusion criteria

  • • Refusal of optical finger sensor and/or acoustic respiratory rate neck sensor placement
  • Finger or skin abnormalities at sensor sites
  • Expected opioid therapy duration less than 24 hours

Treatment and study plan

Primary outcomes

  1. Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events

    Time frame: with in 24 hours post surgery

Secondary outcomes

  1. Time period between detection of first early symptoms of developing sepsis with RRa, PR and SpO2 monitoring compared to the first clinical diagnosis of developing sepsis.

    Time frame: with in 24 hours post surgery

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Masimo Corporation

Registry information

Official study title

Improved Patient Safety Through Continuous Bi-channel Respiratory Rate and Oxygen Saturation Monitoring With Masimo Patient SafetyNet

Acronym: SafetyNet

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2017
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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