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

Conditions
Postoperative Complications
Interventions
Device: Capnostream20p
Registration Number
NCT03275324
Lead Sponsor
Stony Brook University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
600
Inclusion Criteria

18 years or older Planned to undergo general anesthesia for surgery

Exclusion Criteria

Pregnant Inability to consent Mechanically ventilated prior to surgery

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Enrolled patientsCapnostream20pSurgical patients meeting enrollment criteria
Primary Outcome Measures
NameTimeMethod
Postoperative Respiratory EventUp to 2 hours

Respiratory complications occurring after surgery

Secondary Outcome Measures
NameTimeMethod
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