Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02989246 |
Other study ID # |
CHLA-14-00473 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2015 |
Est. completion date |
December 1, 2018 |
Study information
Verified date |
July 2018 |
Source |
Children's Hospital Los Angeles |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This pilot study tests the feasibility of using a computerized ventilator management protocol
seeking to encourage lung protective ventilation during the acute phase of ventilation, and
esophageal manometry based titration of ventilator settings during the weaning phase of
ventilation, for children with acute respiratory failure. The investigators hypothesize that
such an approach will reduce time on mechanical ventilation, largely by preserving diaphragm
muscle function.
Description:
Objectives: This pilot study will help refine a computer based ventilator management protocol
which will be used in both acute and weaning phases of ventilation for children with acute
respiratory failure. The acute phase protocol is an adaptation of the Acute Respiratory
Distress Syndrome Network protocol for pediatrics, and the weaning phase involves an
esophageal manometry guided weaning protocol based on effort of breathing. The investigators
seek to test the safety and feasibility of the protocol recommendations and the software
system , and help determine the potential effect size of the intervention to determine
feasibility of a randomized controlled trial. They also seek to determine the feasibility and
reproducibility of serial diaphragm ultrasound measurements on mechanically ventilated
children.
Study Population: All children intubated and mechanically ventilated in the Children's
Hospital Los Angeles Pediatric ICU with an anticipated length of intubation > 48 hours will
be eligible, with some exclusion criteria based on ability to perform the measurements.
Study methodology: After consent, an esophageal catheter will be placed. A software
management tool for ventilator management will be placed at the bedside for each enrolled
patient, and recommendations regarding changing ventilator support will be provided to the
clinicians every several hours during both acute and weaning phases. When ventilator support
is below a threshold, recommendations will be made to perform spontaneous breathing trials.
The clinicians will ultimately decide whether to accept or reject the recommendations, and
will evaluate the patient before each potential change to the ventilator. The acceptance or
rejection of recommendations will be tracked, and used to refine the intervention. Daily
diaphragm ultrasound measurements will also be obtained to monitor diaphragm thickness and
contractile activity.
Follow up: Clinical outcomes will be followed while in the ICU including re-intubation,
medications administered, and ICU length of stay. No follow up after ICU discharge is
planned.
Analysis plans: Data will be used to refine the intervention, test the acceptability of
protocol recommendations to bedside providers, and determine sample size estimates for a
follow up randomized controlled trial. These analyses will be descriptive. A pilot of 40
patients is anticipated.