Actively Recruiting

Age: 19Years - 80Years
All Genders
ID06400095

Occlusion Pressure at 100 Msec, Expiratory Time Constant, Mechanical Stress Power, Ventilatory Ratio, and C20/Cdyn in Predicting Outcomes in Moderately Severe ARDS Patients on Mechanical Ventilation

Led by CentraCare · Updated on 2024-08-22

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating several ventilatory parameters to predict outcomes in patients with moderately severe Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation. This observational study focuses on measures such as occlusion pressure at 100 milliseconds (Pocc), expiratory time constant (TCe), mechanical stress power, ventilatory ratio, and the C20/Cdyn ratio. The aim is to better understand how these factors relate to patient survival and clinical outcomes during mechanical ventilation in ARDS. The study observes patients from the day of intubation, collecting data over the first three days. Parameters including Pocc, TCe, C20/C index, ventilatory ratio, mechanical stress power, and the PaO2/FiO2 ratio are recorded daily. Researchers also track clinical outcomes such as the need for vasopressors, prone positioning, paralysis, changes in ventilator modes, duration of ventilation, length of ICU and hospital stay, major adverse kidney events, and 30-day survival and disability. Participants will be assessed through routine monitoring of ventilatory and clinical parameters, with data collected in a de-identified manner for analysis. The primary outcome is survival or mortality up to 90 days from enrollment. Secondary outcomes include major adverse kidney events and lengths of ICU and hospital stay. Statistical analyses will explore the predictive value of these ventilatory measures for patient outcomes. The total participant involvement covers initial mechanical ventilation days and follow-up assessments up to 90 days.

CONDITIONS

Brief Title

Ventilatory Parameters in Predicting Outcomes in ARDS Patients

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with acute respiratory failure needing mechanical ventilation
  • Diagnosis of severe ARDS with PF ratio less than 150
  • PEEP or CPAP greater than 5
  • Age between 19 and 80 years
Not Eligible

You will not qualify if you...

  • Ventilator monitoring with r2 less than 0.95
  • Expiratory flow that is not first-order or non-exponential decay
  • Requirement of norepinephrine greater than 0.1 mcg/kg/min within 2 hours of intubation
  • Need for extracorporeal membrane oxygenation (ECMO)
  • COPD or pulmonary fibrosis with premorbid FEV1 less than 1.5 liters
  • Severe atherosclerotic vascular disease
  • Presence of chest tube, intra-abdominal hypertension, or related risk factors
  • Structural heart disease including pulmonary hypertension (RVSP greater than 45) and heart failure
  • Comfort care orders in the ICU
  • Patients who underwent tracheostomy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 3 days

Participants undergo assessment of ventilatory parameters including occlusion pressure, expiratory time constant, mechanical stress power, ventilatory ratio, and C20/Cdyn to predict outcomes while on mechanical ventilation.

Daily assessments for 3 days

Long-term Monitoring

Duration - Up to 90 days

Participants are monitored for outcomes such as survival, major adverse kidney events, ICU and hospital length of stay up to 90 days from enrollment or until death.

Ongoing monitoring up to 90 days

Trial Site Locations

Total: 1 location

1

St Cloud Hospital

Saint Cloud, Minnesota, United States, 56303

Actively Recruiting

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Research Team

R

Ramakanth Pata, MD FCCP

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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