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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03275324
Enrollment
600
Registered
2017-09-07
Start date
2017-09-30
Completion date
2018-09-30
Last updated
2017-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

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.

Interventions

Observational study of patients connected to the Capnostream20p monitor.

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

18 years or older Planned to undergo general anesthesia for surgery

Exclusion criteria

Pregnant Inability to consent Mechanically ventilated prior to surgery

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Respiratory EventUp to 2 hoursRespiratory complications occurring after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026