An interventional study of Ventilator protocol and Esophageal Catheter in Ventilators, Mechanical and Work of Breathing, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 37 Weeks to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment
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.
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 32 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ventilator management using the proposed protocol in both acute and weaning phases. Patients will be managed according the the Ventilator protocol using the esophageal catheter for the weaning phase
Other: Ventilator protocol · Device: Esophageal Catheter
Open loop ventilator management by a computer based protocol
Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations
Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider
The investigators will track the percentage of recommendations which are accepted by providers, as well as the reasons why recommendations were not accepted
Time frame: With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)
| Milestone | Intervention Arm |
|---|---|
| Started | 32 |
| Completed | 32 |
| Not completed | 0 |
The investigators will track the percentage of recommendations which are accepted by providers, as well as the reasons why recommendations were not accepted
| percentage adherant | Intervention Arm |
|---|---|
| Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider | 76 (74.8 to 77.9) |
Collected over During ICU admission. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 7/32 (21.9%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(months) | Intervention Arm |
|---|---|
| Median | 100.7 (30.7 to 150.4) |
| Sex: Female, Male(Participants) | Intervention Arm |
|---|---|
| Female | 13 |
| Male | 19 |
| Race and Ethnicity Not Collected(Participants) | Intervention Arm |
|---|
| Region of Enrollment(participants) | Intervention Arm |
|---|---|
| United States | 32 |
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