Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index: A Randomized Controlled Trial

Conditions
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Mechanical Ventilation Complication, Extubation

Intervention / Treatment
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* Other: IPI monitoring


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPI group<br>IPI monitoring | Other: IPI monitoring<br>* Patients in this arm will have IPI monitoring<br>|
| No Intervention: Control group<br>Standard monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| ICU length of stay | Total ICU day | upto 12 weeks | 
| ICU mortality | Patient status at the time of ICU discharge | upto 12 weeks |