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Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients

NCT03275324 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2017-09-07

No results posted yet for this study

Summary

The Capnostream 20p monitor by Medtronic is FDA-cleared and consists of a monitor which measures real-time respiratory status based on respiratory rate, pulse rate, pulse oximetry (SpO2) and end tidal carbon dioxide (etCO2) with a disposable nasal canula.

The integrated pulmonary index (IPI) is an algorithm driven parameter derived from non-invasive etCO2, respiratory rate, pulse rate and SpO2. Fuzzy logic is used to produce a value from 1-10 with 4 and under requiring intervention and 8-10 representing the normal range.

The purpose of this observational study is to determine if the IPI is associated with complications in the immediate postoperative period.

The study will enroll approximately 600 patients at 2 centers. Clinicians will be blinded to the IPI therefore this device will not be used to guide care in any way.

Conditions

  • Postoperative Complications

Interventions

DEVICE

Capnostream20p

Observational study of patients connected to the Capnostream20p monitor.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Device
Yes

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275324 on ClinicalTrials.gov