Ventilator Protocol for Pediatric Acute Respiratory Distress Syndrome

Recruiting at 8 trial locations

Overseen By Christopher J Newth, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Status asthmaticus, ECLS, cyanotic heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to assist doctors in making better decisions when using ventilators for children with severe lung issues, known as Pediatric Acute Respiratory Distress Syndrome (PARDS). The goal is to determine if the Clinical Decision Support Tool can standardize treatment across different hospitals and possibly reduce the time children need ventilators. Children who have been on a ventilator for lung problems for less than three days and are expected to need it for more than three days may be suitable for this study. The trial will examine whether doctors follow the tool's recommendations and if the tool can automatically record patient data in various hospitals. As an unphased trial, this study provides a unique opportunity to enhance pediatric care and potentially benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this ventilator protocol is safe for pediatric patients?

Research has shown that Clinical Decision Support (CDS) tools help manage acute respiratory distress syndrome (ARDS) and improve patient outcomes. Studies have found that these tools can shorten the time patients spend on ventilators and may reduce death rates in the ICU.

These tools prove especially helpful in children's hospitals, assisting doctors in making better decisions about ventilator use for children with ARDS (PARDS). The tools offer evidence-based advice, which healthcare teams have found useful and follow.

So far, no major reports of negative effects from using these CDS tools have emerged. Instead, they seem to enhance treatment consistency and reduce care differences. This suggests that the tools are safe and well-accepted for managing ventilator settings in children with PARDS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ventilator Protocol for Pediatric Acute Respiratory Distress Syndrome because it introduces a Clinical Decision Support Tool that aims to optimize ventilator management. Unlike traditional methods, which often rely on clinical judgment and standardized settings, this tool offers a tailored approach for both the acute and weaning phases of respiratory distress. By potentially adjusting ventilator settings based on real-time data and patient-specific factors, the protocol aims to improve outcomes and reduce the risk of complications. This personalized strategy could lead to more efficient weaning from mechanical ventilation and better overall recovery for pediatric patients.

What evidence suggests that this ventilator protocol is effective for pediatric acute respiratory distress syndrome?

Research has shown that a Clinical Decision Support (CDS) tool can help doctors manage ventilators more effectively for children with severe breathing problems, known as pediatric acute respiratory distress syndrome (PARDS). In adults with similar issues, studies have found that careful ventilator use can reduce ICU deaths and shorten the duration of ventilator support. In this trial, participants will receive ventilator management using the proposed protocol, supported by the CDS tool, during both acute and weaning phases. The CDS tool aids doctors by providing the best available evidence for making informed decisions about ventilator settings, leading to more consistent care. Previous patients have demonstrated that computerized support like this can improve treatment outcomes. The goal is to ensure that children with PARDS receive the right care at the right time, reducing their time on a ventilator. ^{1 3 6 7 8}

Who Is on the Research Team?

Christopher Newth, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for children over 1 month old and under 18 years who need mechanical ventilation due to severe lung problems (PARDS) and are expected to be on a ventilator for more than 72 hours. It's not for patients whose doctors refuse participation or those with conditions that make certain breathing strategies unsafe.

Inclusion Criteria

My child is on a ventilator due to severe lung disease and meets the age and oxygenation criteria.

You are expected to need a ventilator for more than 72 hours.

I started using a breathing machine less than 3 days ago.

Exclusion Criteria

I cannot undergo standard weaning methods due to severe respiratory or critical conditions.

My primary doctor has decided not to enroll me in the trial.

I do not have conditions like severe brain or lung pressure that prevent certain treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Phase

Patients are managed on the eVentilator protocol during the acute phase of mechanical ventilation

Up to 28 days

Continuous monitoring in PICU

Stable Phase

Patients continue on the eVentilator protocol during the stable phase of mechanical ventilation

Up to 28 days

Continuous monitoring in PICU

Weaning Phase

Patients undergo weaning from mechanical ventilation, including Spontaneous Breathing Tests (SBTs) and Extubation Readiness tests

Up to 28 days

Continuous monitoring in PICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Decision Support Tool

Trial Overview

The study tests a Clinical Decision Support tool designed to help doctors manage ventilators in pediatric ICUs based on the best evidence available. The goal is to see if this tool can standardize care, ensure adherence to recommendations, and potentially shorten time on ventilation.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Ventilator management using the proposed protocol in both acute and weaning phases

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

A survey of 122 physicians in pediatric intensive care units found that 80% of recommendations in a ventilator management protocol for children with acute respiratory distress syndrome were accepted, indicating a general agreement on the protocol's guidelines.

However, there was significant variability in acceptance based on the type of ventilator mode used, with high-frequency oscillatory ventilation being the most accepted, and a lack of consensus on the specific size of changes to ventilator settings, particularly for positive end-expiratory pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Acceptability of a Pediatric Ventilator Management Computer Protocol. Sward, KA., Newth, CJL., Khemani, RG., et al.[2022]

The clinical decision support system for managing mechanical ventilation in 40 ARDS patients was applied for over 10,900 hours, with a high adherence rate of 93% to the generated instructions, indicating its practicality in a clinical setting.

The use of these ventilation protocols resulted in a survival rate of 60% among the patients, suggesting that they are a safe and effective tool for improving outcomes in ARDS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance of a rule-based decision support system for mechanical ventilation of ARDS patients. Thomsen, GE., Pope, D., East, TD., et al.[2020]

The implementation of a Best Practice Alert (BPA) in the electronic health record significantly improved the identification of pediatric acute respiratory distress syndrome (PARDS) patients, reducing false alerts from 66.7% to 29.2%.

Using the Standardized Clinical Assessment and Management Plan (SCAMP) methodology led to increased enrollment of PARDS patients in management protocols from 48.3% to 73.2%, indicating that structured guidelines can enhance adherence to treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Standardized Clinical Assessment and Management Plan for Pediatric Acute Respiratory Distress Syndrome. Rajapreyar, P., Andres, J., Pano, C., et al.[2022]

In a South African pediatric intensive care unit (PICU), a retrospective audit identified a high rate of adverse events (50.8 per 100 patient days) among 80 patients, with catheter complications and hypoglycemia being the most common issues.

The study found that real-time registration during ward rounds reported a lower rate of adverse events (27.2 per 100 patient days) among 236 patients, highlighting that different registration methods can yield varying insights into patient safety and types of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. Vermeulen, JM., van Dijk, M., van der Starre, C., et al.[2014]

In a study of 734 pediatric patients discharged from 15 U.S. PICUs, 62% experienced at least one adverse event (AE), with a notable rate of 28.6 AEs and 4.9 adverse drug events (ADEs) per 100 patient-days, highlighting the high incidence of safety issues in this critical care setting.

The research identified that surgical patients, those who were intubated, and patients who died had significantly higher rates of AEs and ADEs, indicating specific population characteristics that increase risk and emphasizing the need for targeted prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events in pediatric intensive care units in the United States. Agarwal, S., Classen, D., Larsen, G., et al.[2022]

The implementation of a protocolized ventilator weaning pathway in a pediatric intensive care unit significantly reduced the duration of mechanical ventilation by a median of 3.6 days for children with acute respiratory distress syndrome, based on a study of 585 survivors.

Importantly, this intervention did not increase reintubation rates, indicating that the weaning process was safe and effective without compromising patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilator-Weaning Pathway Associated With Decreased Ventilator Days in Pediatric Acute Respiratory Distress Syndrome. Mehta, SD., Martin, K., McGowan, N., et al.[2023]

The Pediatric Acute Lung Injury Consensus Conference established 27 recommendations for managing mechanical ventilation in children with acute respiratory distress syndrome, with 17 recommendations receiving strong agreement from experts.

Key recommendations include using positive end-expiratory pressure levels greater than 15 cm H2O in severe cases while closely monitoring patient conditions, and a strong endorsement for recruitment maneuvers during rescue high-frequency oscillatory ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilatory support in children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Rimensberger, PC., Cheifetz, IM.[2015]

A panel of 27 experts developed 151 recommendations for assessing outcomes in pediatric acute respiratory distress syndrome (ARDS), emphasizing the need for consistent care and further research, particularly regarding long-term effects in children.

Children with ARDS face high mortality risks, especially with comorbidities like immunocompromised states and conditions such as non-pulmonary sepsis, highlighting the importance of understanding long-term consequences to improve treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcomes of children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Quasney, MW., López-Fernández, YM., Santschi, M., et al.[2022]

In a study observing medication use in a pediatric ICU, 58 incidents of medication errors and adverse drug events (ADEs) were identified, with 81% of medication errors deemed clinically important, highlighting significant safety concerns in this setting.

The study found a rate of 3.6 actual and 9.8 potential ADEs per 100 orders, indicating that direct observation can reveal higher rates of medication errors compared to other reporting methods, suggesting the need for ongoing monitoring to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct observation approach for detecting medication errors and adverse drug events in a pediatric intensive care unit. Buckley, MS., Erstad, BL., Kopp, BJ., et al.[2022]

A new pediatric trigger tool was developed to identify adverse events (AEs) in hospitalized children, revealing that 34% of patients experienced a total of 563 AEs, with 442 of these being preventable.

The study found that AEs are common in pediatric patients, and the tool can help healthcare organizations improve patient safety by measuring and analyzing these events across different clinical specialties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of triggers and development of a pediatric trigger tool to identify adverse events. Unbeck, M., Lindemalm, S., Nydert, P., et al.[2018]

In a study of 259 critically ill pediatric patients, preventable adverse events occurred at a rate of 0.19 events per patient-day, with most being minor in severity, indicating that while these events are common, serious harm is rare.

Younger patients with longer hospital stays and higher illness burdens were more likely to experience preventable adverse events, particularly those requiring sedation or medical devices, suggesting that targeted monitoring and intervention strategies could help reduce these incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventable harm occurring to critically ill children. Larsen, GY., Donaldson, AE., Parker, HB., et al.[2022]

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