NCT03275324

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Capnostream20p	Observational study of patients connected to the Capnostream20p monitor.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2017-09-07
• Last updated: 2017-09-07

Regulatory

• FDA-regulated device study