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Usual care for Acute Respiratory Distress Syndrome

N/A
Waitlist Available
Led By Robert Hyzy, MD
Research Sponsored by University of Michigan
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 participants received treatment 1 (either usual care or peep eit) for approximately 6 hours after randomization and then received treatment 2 for an additional 14-18 hours following crossover. measurement was done at baseline and end of treatment.
Awards & highlights

Study Summary

This study is evaluating whether a new device can help doctors optimize the amount of oxygen into the lungs.

Eligible Conditions
  • Acute Respiratory Distress Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants received treatment 1 (either usual care or peep eit) for approximately 6 hours after randomization and then received treatment 2 for an additional 14-18 hours following crossover. measurement was done at baseline and end of treatment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants received treatment 1 (either usual care or peep eit) for approximately 6 hours after randomization and then received treatment 2 for an additional 14-18 hours following crossover. measurement was done at baseline and end of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mechanical Power
Secondary outcome measures
Change in Compliance Over the Last 20% of Inspiration (C20/Dyn)
Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio)
Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure
+5 more

Side effects data

From 2012 Phase 3 trial • 844 Patients • NCT01336205
18%
ABDOMINAL PAIN
14%
DIARRHOEA
10%
NAUSEA
9%
BACK PAIN
9%
HEADACHE
7%
FLATULENCE
6%
ABDOMINAL PAIN UPPER
6%
ARTHRALGIA
6%
BRONCHITIS
6%
NASOPHARYNGITIS
6%
UPPER RESPIRATORY TRACT INFECTION
5%
URINARY TRACT INFECTION
5%
VOMITING
5%
COUGH
4%
FALL
4%
PAIN IN EXTREMITY
4%
SINUSITIS
3%
FATIGUE
3%
PYREXIA
3%
NASAL CONGESTION
3%
MUSCLE SPASMS
3%
HYPERTENSION
3%
GASTROENTERITIS VIRAL
3%
ANXIETY
3%
INSOMNIA
3%
HYPERHIDROSIS
2%
CHILLS
2%
DIZZINESS
2%
ABDOMINAL DISCOMFORT
2%
ABDOMINAL DISTENSION
2%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
OEDEMA PERIPHERAL
2%
CONTUSION
2%
INFLUENZA
2%
DEPRESSION
1%
DEHYDRATION
1%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
1%
HYPERCHOLESTEROLAEMIA
1%
PNEUMONIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
NKTR-118 25 mg
Usual Care

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual care then PEEP titration by Electrical Impedance Tomography (EIT)Experimental Treatment2 Interventions
Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan Acute Respiratory Distress Syndrome (ARDS) protocol high-PEEP arm
Group II: PEEP titration by EIT then usual careExperimental Treatment2 Interventions
Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PEEP titration by EIT
2019
N/A
~20

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,900 Total Patients Enrolled
Robert Hyzy, MDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome
Robert C. Hyzy, MD 2019. "Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03793842.
~3 spots leftby Apr 2025
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