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

NCT ID: NCT03043911

Last Updated: 2017-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Signs and Symptoms, Respiratory

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role collaborator

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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014-293

Identifier Type: -

Identifier Source: org_study_id

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