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

Signs and Symptoms, Respiratory Clinical Trial

— SafetyNet  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03043911
• Other study ID #: 014-293
• Status: Active, not recruiting
• Phase: N/A
• First received: January 31, 2017
• Last updated: June 9, 2017
• Start date: February 2016
• Est. completion date: July 2019

Study information

• Verified date: June 2017
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Signs and Symptoms
• Signs and Symptoms, Respiratory

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Masimo Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved sensitivity of RRa by detecting the number and the incidence rate of respiratory depression events		with in 24 hours post surgery
Secondary	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