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Device
Ventilator Safety for Lung Injury (ASOP Trial)
N/A
Waitlist Available
Led By Neil R MacIntyre, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up index hospitalization (up to 28 days)
Awards & highlights
ASOP Trial Summary
This trial will help researchers understand how well different ways of assessing self-induced lung injury work.
Who is the study for?
This trial is for adults over 18 with acute respiratory failure who are on pressure-support ventilation. It's not for those who've had recent esophageal or stomach surgeries, can't consent, are pregnant or incarcerated, have certain lung conditions, known esophageal varices, or if their doctor thinks a catheter isn't safe due to other reasons.Check my eligibility
What is being tested?
The study compares three methods of assessing the risk of patients causing themselves lung injury while on ventilators. It involves using different devices like the Vyaire SmartCath and various ventilators to see which method aligns best with the gold standard measurement.See study design
What are the potential side effects?
Potential side effects may include discomfort from the nasogastric tube placement, risks associated with mechanical ventilation such as pneumonia or barotrauma (injury caused by increased air pressure), and possible complications from using monitoring devices.
ASOP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ index hospitalization (up to 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~index hospitalization (up to 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Airway Occlusion Test (AOC)
Respiratory System Driving Pressure measure by Respironics NM3 device (DPrs-NM3)
Respiratory System Driving Pressure measure by Servo Ventilator (DPrs-servo)
+2 moreSecondary outcome measures
Duration of hospital admission
Duration of intensive care unit admission
Duration of mechanical ventilation
+2 moreASOP Trial Design
1Treatment groups
Experimental Treatment
Group I: Acute Respiratory FailureExperimental Treatment4 Interventions
Patients with acute respiratory failure managed with pressure-support ventilation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vyaire SmartCath adult nasogastric tube with Esophageal balloon
2022
N/A
~20
Viasys Avea Ventilator
2022
N/A
~20
Philips Respironics NM3 device
2022
N/A
~20
Servo U ventilator
2022
N/A
~20
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,054 Total Patients Enrolled
2 Trials studying Acute Respiratory Failure
2,420 Patients Enrolled for Acute Respiratory Failure
Neil R MacIntyre, MDPrincipal InvestigatorProfessor of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had surgery on your esophagus, stomach, or duodenum in the past 6 months.You are currently experiencing a sudden worsening of a lung disease that causes breathing difficulties.You have a condition that makes it unsafe for a doctor to use a tube in your mouth or stomach.Currently participating in another clinical trial.Using a specific type of assisted breathing machine.You are an adult over 18 years old and are currently on a breathing machine for severe breathing problems.
Research Study Groups:
This trial has the following groups:- Group 1: Acute Respiratory Failure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant count of this experimental therapy?
"Yes, the clinical trial is currently recruiting. According to information posted on clinicaltrials.gov, this study was first announced on February 8th 2022 and most recently updated November 15th of that same year. The research team requires 20 individuals at 1 facility for participation in the experiment."
Answered by AI
What is the stated purpose of this research undertaking?
"The research team will be assessing the primary outcome of Respiratory System Driving Pressure (DPrs-servo) over a set Study day 1 time frame. Secondary objectives include tracking Duration of mechanical ventilation, hospital admission and intensive care unit stay in terms of days spent receiving treatment for each respective area."
Answered by AI
Are there any slots available for this research program?
"Affirmative, according to data presented on clinicaltrials.gov this medical trial is actively looking for volunteers. The study was first posted on February 8th 2022 and the details were most recently updated November 15th 2022 - with a total of 20 participants being accepted from 1 site currently."
Answered by AI
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