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

Mechanical Ventilation Complication Clinical Trial

— IPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231890
• Other study ID #: 18112803
• Status: Completed
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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)

Related Conditions & MeSH terms

• Extubation
• Mechanical Ventilation Complication

Intervention

Other:
• IPI monitoring
Patients in this arm will have IPI monitoring

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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