NCT03275324|UnknownFDA Device
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Sponsor study identifier
observational
600
0 countries
N/A
Study Start
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 5, 2017
Actual (reported)September 7, 2017
Actual (reported)September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Postoperative Respiratory Event
Respiratory complications occurring after surgery
Up to 2 hours
Surgical patients meeting enrollment criteria
Observational study of patients connected to the Capnostream20p monitor.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Surgical patients
First Submitted
September 5, 2017
First Posted
September 7, 2017
Study Start
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2018
Estimated (date passed)Preoperative High Dose Steroids for Liver Resection- Effect on Complications in the Immediate Postoperative Period
Crystalloids vs Albumin Prime Solution and Postoperative Pulmonary Complications
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 7, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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