NCT03043911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

September 19, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

March 2, 2026

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

January 31, 2017

Last Update Submit

February 26, 2026

Conditions

Signs and Symptoms, Respiratory

Keywords

early detectionrespiratory eventssepsis

Outcome Measures

Primary Outcomes (1)

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

    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.

    with in 24 hours post surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients to be admitted to the general post surgical floor who meet the inclusion and exclusion criteria will be enrolled after signing the study consent form.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Signs and Symptoms, RespiratorySepsis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 6, 2017

Study Start

September 19, 2017

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

March 2, 2026

Record last verified: 2025-11

Locations

US(1)