Mechanical Ventilation Complication Clinical Trial
— IPIOfficial title:
Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index: A Randomized Controlled Trial
NCT number | NCT04231890 |
Other study ID # | 18112803 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2020 |
Est. completion date | April 1, 2021 |
Verified date | April 2021 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of this study is to compare reintubation rate when using standard medical therapy (SMT) versus a monitoring tool, Integrated Pulmonary Index (IPI), to alert clinicians of the patient's respiratory status and need for therapy after planned extubation.
Status | Completed |
Enrollment | 174 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult subjects 18 years and older, endotracheally intubated and receiving assisted mechanical ventilation for more than 24hours, and - Subjects under planned extubation based on the medical team approval Exclusion Criteria: - Subjects who are less than 18 years old, - are pregnant, - have tracheostomy tube as they do not qualify for extubation, - have do-not-resuscitate or do-not-intubate orders, - accidental or self-extubated patients, - reintubation after study enrollment, - are extubated terminally, or - receiving extracorporeal membrane oxygenation (ECMO) |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reintubation rate at 72hours | Reintubation rate defined as requiring re-intubation and returning to mechanical ventilation within 72 hours after the initial discontinuation from the ventilation due to respiratory failure | 72 hours | |
Secondary | Reintubation rate at 7 days | Reintubation rate defined as requiring re-intubation and returning to mechanical ventilation within 7 days after the initial discontinuation from the ventilation due to respiratory failure | 7 days | |
Secondary | ICU length of stay | Total ICU day | upto 12 weeks | |
Secondary | ICU mortality | Patient status at the time of ICU discharge | upto 12 weeks |
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