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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2021-04-01

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.

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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.

Conditions

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Mechanical Ventilation Complication Extubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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IPI group

IPI monitoring

Group Type EXPERIMENTAL

IPI monitoring

Intervention Type OTHER

Patients in this arm will have IPI monitoring

Control group

Standard monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IPI monitoring

Patients in this arm will have IPI monitoring

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No