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Completed

NCT Number: NCT04231890

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IPI monitoring

Other

Patients in this arm will have IPI monitoring

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Acronym: IPI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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