Clinical trial NCT04231890: Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index
Official title: Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Extubation
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reintubation rate at 72hours
timeFrame: 72 hours
Secondary outcomes:
measure: Reintubation rate at 7 days
timeFrame: 7 days
measure: ICU length of stay
timeFrame: upto 12 weeks
measure: ICU mortality
timeFrame: upto 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: David Vines, PhD
role: STUDY_CHAIR
References:
citation: Kaur R, Vines DL, Harnois LJ, Elshafei A, Johnson T, Balk RA. Identification and Prevention of Extubation Failure by Using an Automated Continuous Monitoring Alert Versus Standard Care. Respir Care. 2022 Oct;67(10):1282-1290. doi: 10.4187/respcare.09860. Epub 2022 Mar 28.