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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03043911

Acronym

SafetyNet

Enrollment

Registered

2017-02-06

Start date

2017-09-19

Completion date

2021-11-10

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Signs and Symptoms, Respiratory

Keywords

early detection, respiratory events, sepsis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events	with in 24 hours post surgery

Secondary

Measure	Time frame
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.	with in 24 hours post surgery

Countries

United States

Outcome results