Clinical trial NCT01795196: Integrated Pulmonary Index (IPI) as a Determinate of Weaning Success and/or Failure in the Pediatric Population
Official title: The Use of Integrated Pulmonary Index (IPI) as a Determinate of Weaning Success and/or Failure in the Pediatric Population
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Insufficiency
Keywords: pediatric extubation failure
weaning
integrated pulmonary index
mechanical ventilation
extubation readiness
respiratory monitoring tool
Endotracheal Extubation
Pediatric Intensive Care Unit
Rapid Shallow Breathing Index
Physiologic Deadspace
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated pediatric patients undergoing the weaning process.

Brief summary: Integrated pulmonary index (IPI) is a tool that monitors respiratory status. It takes into account four parameters: respiratory rate, end-tidal CO2, heart rate and O2 saturation using a pulse oximeter and specialized sidestream CO2 monitor. The device can continuously monitor and display the patient's ventilatory state as a single digit, 1-10. In addition, trends can be kept and it can provide early indication of changes in respiratory status. IPI has only been studied in pediatric patients who are under sedation; however, more uses for the monitoring tool are a possibility. One of those possibilities is to use IPI to monitor pediatric patients during the weaning and extubation process to determine if a specific number, or less than a specific number, is associated with extubation failure. Therefore, clinicians and physicians would be better able to determine if the patient is ready for extubation.

Detailed description: This is an prospective observational study designed to collect data on the IPI in mechanically ventilated pediatric patients undergoing the weaning process and extubation using the FDA approved Capnostream 20® bedside monitor (CS20) (Covidien Inc., Mansfield, MA, USA). Inclusion criteria include patients intubated at least 24 hours who are less than 18 years of age but greater than 1 year of age. Exclusion criteria include patients less than 1 year of age or the presence of a tracheostomy tube. The IPI number will be blinded throughout the study but directly monitored values (SpO2, HR, PETCO2, RR) will be available for clinical use.

Upon meeting inclusion criteria, the subject will be given a code number to protect their identity. Study personnel will verify that the CS20 monitor matches the institutional time/date prior to use and the de-identified subject ID will be entered in the CS20 monitor. The subject will be connected to the CS20 device via a pulse oximeter probe and a CO2 sampling line attached to the ventilator circuit, both are standard of care in monitoring ventilated pediatric patients. Subjects will be monitored for 10 minutes prior to the initiation of physician directed weaning evaluation or extubation. Study personnel will verify that the IPI number on the monitor is not visible to clinicians in order to prevent changes on routine interventions.

Investigators will record date, time, and mechanical ventilator settings when the CS20 monitor is started to collect baseline data. Physician directed weaning trials or ventilator changes to test readiness for extubation will be recorded to correlate IPI values at a later date. Venous and/or arterial blood gas (ABG) data and nebulizer treatments occurring during the study will be recorded along with the PETCO2 when the ABG is drawn or nebulizer treatment administered and CS20 monitor will be marked with an event. For nebulizer treatments, mark event and also push the pump off button to pause IPI monitoring for 15 minutes in order to prevent sample line from becoming clogged. CS 20 IPI monitoring will automatically resume 15 minutes after pausing the pump. If the weaning trial is stopped or the patient is extubated, the date and time will be recorded and the monitor will be marked with an event. Subjects that fail the weaning readiness determination will have the process repeated for up to three weaning attempts. If not weaned from mechanical ventilation after the third attempt, participation in the trial will be terminated. Participation in the study will be terminated if extubation does not occur within 72 hours of enrollment.

If extubated, the event will be marked on the monitor and the date and time will be recorded on the case report form (CRF). After extubation, the subject will remain reconnected to the CS20 monitor via a PETCO2 sampling nasal cannula capable of providing supplemental oxygen and a pulse oximeter. Subjects will continue to be monitored for up to 48 hours post extubation or until transferred out of the ICU. If a subject fails extubation and requires re-intubation or use of noninvasive ventilation, the event and time will be recorded and the study will be terminated. The subject may withdraw from the study at anytime or the attending physician may terminate their participation in the trial.

Necessary protected health information (PHI) includes subject name and medical record number to track the subject at 48 hours post extubation. PHI will be maintained on a site enrollment log separate from any collected data in a locked file cabinet.

Quantitative data for this study will include the time stamped electronic parameter data by subject ID from the CS20; the CRF with de-identified demographic information, significant pulmonary medical history, ventilator parameters prior to extubation, method used to determine readiness to discontinue mechanical ventilation, number of days on mechanical ventilator, rapid shallow breathing index, VD/VT, ABG and co-morbidity, date and time of extubation and 48 hour post extubation status.

Time stamped electronic parameter data from the CS20 will be obtained from the monitor via a USB drive. Data from the CS20 will be stored in a secure computer by subject ID number. The de-identified subject demographic information, medical and pulmonary history will be obtained from the subject's electronic medical record by the study staff and recorded on the CRF. The CRFs will be stored in a Study Binder in a locked filling cabinet in the College of Sciences. The Study Binder will be stored in a secure location and the data will be retained for three years.

Eligibility criteria: Inclusion

* Intubated at least 24 hours
* Less than 18 years of age
* Greater than 1 year of age
* Enrollment will be stratified based upon the time a potential subject has received MV.

Exclusion

* Patients less than 1 year of age
* Presence of a tracheostomy tube

Primary outcomes:
measure: To determine if IPI predicts extubation success.
timeFrame: 48 hours post extubation
Secondary outcomes:
measure: To compare IPI to RSBI and VD/VT.
timeFrame: Measured prior to extubation
measure: To assess is there is a correlation between PaCO2 and PetCO2.
timeFrame: Measured with each blood gas drawn
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center- Rush Children's Hospital
state: Illinois
Study officials:
affiliation: Chair and Program Director, Department of Respiratory Care
name: David L Vines, MS
role: PRINCIPAL_INVESTIGATOR
References: