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

NCT ID: NCT03275324

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-30

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Enrolled patients

Surgical patients meeting enrollment criteria

Capnostream20p

Intervention Type DEVICE

Observational study of patients connected to the Capnostream20p monitor.

Interventions

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Capnostream20p

Observational study of patients connected to the Capnostream20p monitor.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

18 years or older Planned to undergo general anesthesia for surgery

Exclusion Criteria

Pregnant Inability to consent Mechanically ventilated prior to surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1037010

Identifier Type: -

Identifier Source: org_study_id

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