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Ventilator Protocol for Pediatric Acute Respiratory Distress Syndrome

N/A

Recruiting

Led By Christopher J Newth, MD

Research Sponsored by Children's Hospital Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children > 1 month of age and >44 weeks gestation and ≤ 18 years of age supported on mechanical ventilation with pulmonary parenchymal disease (i.e. Pediatric Acute Respiratory Distress Syndrome (PARDS)) with Oxygen Saturation Index (OSI) ≥ 5) or Oxygenation Index (OI) ≥ 4

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.

Awards & highlights

Study Summary

This trial is testing a computer program that gives doctors recommendations on how to ventilate children with a certain lung disease. They want to see if the program is usable in different hospitals and if it leads to shorter ventilator use.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves implementing a decision support protocol rather than a drug, there aren't direct side effects like medications have. However, changes in ventilator management could impact patient comfort or respiratory function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion - each patient will be capped at 28 days, limitation of care, or death, whichever comes first. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim 1: Implementation Feasibility

Aim 2: Protocol Adherence

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor

232 Previous Clinical Trials

5,076,344 Total Patients Enrolled

Christopher J Newth, MDPrincipal InvestigatorChildren's Hospital Los Angeles

1 Previous Clinical Trials

55 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being welcomed for this experiment?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is recruiting patients at present. The study was first posted in December 1st 2020 and most recently revised as of March 3rd 2022; 180 individuals must be recruited from 7 different sites for its completion."

Answered by AI

Does this clinical trial include participants aged 20 and above?

"As indicated by the trial's entry requirements, the age range for enrollment is between 1 month and 18 years."

Answered by AI

In which geographic regions is this clinical experiment supervised?

"This medical research is recruiting participants from Children's Hospital of Wisconsin in Milwaukee, Pennsylvania, Penn State University in Hershey, Quebec, and CHU Sainte-Justine in Montréal along with seven other sites."

Answered by AI

Are there any vacancies in the experiment for volunteers?

"The records posted on clinicaltrials.gov demonstrate that this research project is actively accepting participants. The initiative was first announced in December of 2020 and last updated earlier this year, March 3rd 2022."

Answered by AI

Do I meet the qualifications to join this research initiative?

"Acceptance criteria for this research requires that patients have ventilator-induced lung injury and be aged between 1 month to 18. 180 participants are targeted by the study team."

Answered by AI

Recent research and studies

Pediatric Critical Care MedicineJournal

Real-time Effort Driven Ventilator Management: A Pilot Study*

Hotz, Justin C., Dinnel Bornstein, Kristen Kohler, Erin Smith, Anil Suresh, Margaret Klein, Anoopindar Bhalla, Christopher J. Newth, and Robinder G. Khemani. 2020. “Real-time Effort Driven Ventilator Management: A Pilot Study*”. Pediatric Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pcc.0000000000002556.

Contemporary Clinical TrialsJournal

A Phase II Randomized Controlled Trial for Lung and Diaphragm Protective Ventilation (real-time Effort Driven Ventilator Management)

Khemani, Robinder G., Justin C Hotz, Margaret J. Klein, Jeni Kwok, Caron Park, Christianne Lane, Erin Smith, et al.. 2020. “A Phase II Randomized Controlled Trial for Lung and Diaphragm Protective Ventilation (real-time Effort Driven Ventilator Management)”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2019.105893.

clinicaltrials.govStudy

Clinical Decision Support Tool in PARDS Pilot Study

Christopher J. L. Newth, MD 2020. "Clinical Decision Support Tool in PARDS Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04068012.

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