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

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ClinicalTrials.gov Identifier: NCT04231890
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Ramandeep Kaur, 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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Extubation Other: IPI monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Early Identification and Prevention of Extubation Failure in Adults Using Integrated Pulmonary Index: A Randomized Controlled Trial
Actual Study Start Date : March 9, 2020
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : April 1, 2021

Arm Intervention/treatment
Experimental: IPI group
IPI monitoring
Other: IPI monitoring
Patients in this arm will have IPI monitoring

No Intervention: Control group
Standard monitoring



Primary Outcome Measures :
  1. Reintubation rate at 72hours [ Time Frame: 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 :
  1. Reintubation rate at 7 days [ Time Frame: 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

  2. ICU length of stay [ Time Frame: upto 12 weeks ]
    Total ICU day

  3. ICU mortality [ Time Frame: upto 12 weeks ]
    Patient status at the time of ICU discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231890


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Study Chair: David Vines, PhD Rush University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ramandeep Kaur, Research Coordinator; MSc, RRT-ACCS, AE-C, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04231890    
Other Study ID Numbers: 18112803
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No