Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index
- Conditions
- ExtubationMechanical Ventilation Complication
- Interventions
- Other: IPI monitoring
- Registration Number
- NCT04231890
- Lead Sponsor
- Rush University Medical Center
- Brief Summary
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.
- Detailed Description
The study is designed as a randomized controlled trial to compare two methods to guide application of clinical interventions after planned extubation: SMT versus IPI based clinical management among adult patients admitted in the ICU and receiving mechanical ventilation for ≥24 hours. Each mechanically ventilated subject within the inclusion criteria and with a physician order for extubation will be randomized to either the SMT or IPI based clinical management group. Once the extubation order is placed by the medical team, the patient will be randomized to IPI monitoring group or standard medical management group. Patients randomized to IPI group will be placed on IPI monitoring after extubation.Respiratory Therapist (RT) will extubate and connects the patient to EtCO2 cannula (Medtronic, Minneapolis, MN) and will turn on IPI monitoring on the Philips monitor. Any subject with decrease in IPI by 1 within 1 hour of extubation or IPI ≤ 4 after 1 hour of extubation will be assessed by RT and will receive standard medical therapy based on respiratory department protocols. IPI monitoring will be continued for up to 72 hours after extubation. Patients randomized to control group will receive standard medical therapy based on the respiratory department protocols. All patients will be clinically monitored for 72 hours after extubation to assess the extubation outcome. Patients that require reintubation will be reintubated based on the medical team decision and will be discontinued from the study. Patients that do not require reintubation after 72 hours will successfully complete the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IPI group IPI monitoring IPI monitoring
- Primary Outcome Measures
Name Time Method Reintubation rate at 72hours 72 hours 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
- Secondary Outcome Measures
Name Time Method ICU length of stay upto 12 weeks Total ICU day
Reintubation rate at 7 days 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
ICU mortality upto 12 weeks Patient status at the time of ICU discharge
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States