Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01795196 |
| Other study ID # |
10110203-IRB01 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2011 |
| Est. completion date |
September 15, 2017 |
Study information
| Verified date |
December 2022 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
