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

Stony Brook University

Status: Unknown

Conditions: Postoperative Complications

Treatments: Device: Capnostream20p

Study type: Observational

Funder types: Other

Identifiers

NCT03275324

1037010

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

18 years or older Planned to undergo general anesthesia for surgery

Exclusion criteria

Pregnant Inability to consent Mechanically ventilated prior to surgery

Trial design

600 participants in 1 patient group

Enrolled patients

Description:

Surgical patients meeting enrollment criteria

Treatment:

Device: Capnostream20p