Study Stopped
Lack of subjects to participate
Integrated Pulmonary Index (IPI) as a Determinate of Weaning Success and/or Failure in the Pediatric Population
IPI
The Use of Integrated Pulmonary Index (IPI) as a Determinate of Weaning Success and/or Failure in the Pediatric Population
1 other identifier
observational
N/A
1 country
1
Brief Summary
Integrated pulmonary index (IPI) is a tool that monitors respiratory status. It takes into account four parameters: respiratory rate, end-tidal CO2, heart rate and O2 saturation using a pulse oximeter and specialized sidestream CO2 monitor. The device can continuously monitor and display the patient's ventilatory state as a single digit, 1-10. In addition, trends can be kept and it can provide early indication of changes in respiratory status. IPI has only been studied in pediatric patients who are under sedation; however, more uses for the monitoring tool are a possibility. One of those possibilities is to use IPI to monitor pediatric patients during the weaning and extubation process to determine if a specific number, or less than a specific number, is associated with extubation failure. Therefore, clinicians and physicians would be better able to determine if the patient is ready for extubation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 13, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2017
CompletedDecember 28, 2022
December 1, 2022
6.4 years
February 13, 2013
December 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine if IPI predicts extubation success.
The IPI number will be compared to extubation success or failure to evaluate the usefulness of the IPI as a predictor.
48 hours post extubation
Secondary Outcomes (2)
To compare IPI to RSBI and VD/VT.
Measured prior to extubation
To assess is there is a correlation between PaCO2 and PetCO2.
Measured with each blood gas drawn
Eligibility Criteria
Mechanically ventilated pediatric patients undergoing the weaning process.
You may qualify if:
- Intubated at least 24 hours
- Less than 18 years of age
- Greater than 1 year of age
- Enrollment will be stratified based upon the time a potential subject has received MV.
You may not qualify if:
- Patients less than 1 year of age
- Presence of a tracheostomy tube
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center- Rush Children's Hospital
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David L Vines, MS
Chair and Program Director, Department of Respiratory Care
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair and Program Director, Department of Respiratory Care
Study Record Dates
First Submitted
February 13, 2013
First Posted
February 20, 2013
Study Start
May 1, 2011
Primary Completion
September 15, 2017
Study Completion
September 15, 2017
Last Updated
December 28, 2022
Record last verified: 2022-12