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

NCT03275324 | Unknown FDA Device

• 1 other identifier: 1037010
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative Respiratory Event

  Respiratory complications occurring after surgery

  Up to 2 hours

Study Arms (1)

Enrolled patients

Surgical patients meeting enrollment criteria

Device: Capnostream20p

Interventions

Capnostream20p DEVICE

Observational study of patients connected to the Capnostream20p monitor.

Enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients

You may qualify if:

• years or older Planned to undergo general anesthesia for surgery

You may not qualify if:

• Pregnant Inability to consent Mechanically ventilated prior to surgery

Sponsors & Collaborators

• Stony Brook University: lead

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 7, 2017

Record last verified: 2017-09