Ventilator Protocol for Pediatric Acute Respiratory Distress Syndrome

Recruiting at 7 trial locations

Overseen by Christopher Newth, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital Los Angeles

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Previous clinical trials in adults with acute respiratory distress syndrome (ARDS) have demonstrated that ventilator management choices can improve Intensive Care Unit (ICU) mortality and shorten time on mechanical ventilation. This study seeks to scale an established Clinical Decision Support (CDS) tool to facilitate dissemination and implementation of evidence-based research in mechanical ventilation of infants and children with pediatric ARDS (PARDS). This will be accomplished by using CDS tools developed and deployed in Children's Hospital Los Angeles (CHLA) which are based on the best available pediatric evidence, and are currently being used in an NHLBI funded single center randomized controlled trial (NCT03266016, PI: Khemani). Without CDS, there is significant variability in ventilator management of PARDS patients both between and within Pediatric ICUs (PICUs), but clinicians are willing to accept CDS recommendations. The CDS tool will be deployed in multiple PICUs, targeting enrollment of up to 180 children with PARDS. Study hypotheses: 1. The CDS tool in will be implementable in nearly all participating sites 2. There will be \> 80% compliance with CDS recommendations and 3. The investigators can implement automatic data capture and entry in many of the ICUs Once feasibility of this CDS tool is demonstrated, a multi-center validation study will be designed, which seeks to determine whether the CDS can result in a significant reduction in length of mechanical ventilation (LMV).

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 data supports the effectiveness of the treatment Clinical Decision Support Tool for Pediatric Acute Respiratory Distress Syndrome?

A study on a similar decision support system for adults with respiratory distress showed that it was practical and safe, with a high adherence rate to its recommendations and a survival rate of 60% among patients. This suggests that a similar tool for children could also be effective in managing their condition. ^{1 2 3 4 5}

Is the ventilator protocol for pediatric acute respiratory distress syndrome generally safe for children?

The research articles focus on identifying and preventing adverse events in pediatric intensive care units, which can help improve safety. However, they do not provide specific safety data for the ventilator protocol or clinical decision support tool for pediatric acute respiratory distress syndrome. ^{6 7 8 9 10}

How is the ventilator protocol treatment for pediatric acute respiratory distress syndrome different from other treatments?

This treatment is unique because it uses a protocolized approach to manage ventilator settings, which can help reduce the duration of mechanical ventilation and the length of stay in the pediatric intensive care unit. It involves a structured decision support system that guides healthcare providers in adjusting ventilator settings, making it more systematic compared to traditional methods. ^{1 2 3 4 11}

Research Team

Christopher Newth, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Clinical Decision Support Tool (Behavioural Intervention)

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.

Participant Groups

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+

Paul S. Viviano

Children's Hospital Los Angeles

Chief Executive Officer since 2015

Master of Public Health from UCLA Fielding School of Public Health

Alan S. Wayne

Children's Hospital Los Angeles

Chief Medical Officer since 2023

MD

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Potential Acceptability of a Pediatric Ventilator Management Computer Protocol. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical performance of a rule-based decision support system for mechanical ventilation of ARDS patients. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The outcomes of children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ventilator-Weaning Pathway Associated With Decreased Ventilator Days in Pediatric Acute Respiratory Distress Syndrome. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Development of a Standardized Clinical Assessment and Management Plan for Pediatric Acute Respiratory Distress Syndrome. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Direct observation approach for detecting medication errors and adverse drug events in a pediatric intensive care unit. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events in pediatric intensive care units in the United States. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Validation of triggers and development of a pediatric trigger tool to identify adverse events. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Preventable harm occurring to critically ill children. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

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