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NCT03275324 Clinical Trial

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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03275324
Other study ID # 1037010
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 5, 2017
Last updated September 5, 2017
Start date September 2017
Est. completion date September 2018

Study information
Verified date September 2017
Source Stony Brook University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Capnostream20p
Observational study of patients connected to the Capnostream20p monitor.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Stony Brook University

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Respiratory Event Respiratory complications occurring after surgery Up to 2 hours
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