Ventilatory Parameters in Predicting Outcomes in ARDS Patients

NCT06400095 | Recruiting

• 1 other identifier: RAMOCTANE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre prospective observational study aimed to determine if Pocc (occlusion pressure at 100 msec), TCe ( Expiratory time constant ), Mechanical Stress power, Ventilatory ratio and C20/Cdyn would predict outcomes in patients with moderately severe ARDS (Acute respiratory distress syndrome), who are on mechanical ventilation

Conditions

ARDS; Mechanical Power

Keywords

Expiratory time constant; Ventilator ratio; Cdyn/C20; Occlusion pressure at 100 msec

Outcome Measures

Primary Outcomes (1)

• Survival or mortality

  We will assess whether the patient would survive or not

  From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days.

Secondary Outcomes (2)

• MAKE ( Major adverse kidney events)

  From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days.

• ICU and Hospital length of stay

  From the date of enrollment to the number of days in ICU and in the hospital until discharge or date of death whichever came first, assessed up to 90 days

Interventions

Poccl, Time constant, driving pressure DIAGNOSTIC_TEST

Ventilatory parameters

Also known as: mechanical power

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For those patients, who satisfy inclusion and exclusion criteria, Day 1 will be considered as the the day of intubation. Age , gender, Charleston co-morbidity index , SOFA score at the time of intubation. For day 1 to day 3, we shall record average values of Pocc, TCe, C20/C index, Ventilatory ratio, Mechanical stress power , PF ratio will be recorded. Outcome data such as need for vasopressors, prone position, duration of ICU stay, MAKE outcomes, need for paralysis, change in mode of ventilator, ventilator number of days, hospital stay and 30 days outcomes including disability and survival.

You may qualify if:

• Patients with Acute respiratory failure needing mechanical ventilation
• Diagnosis of Severe ARDS with severity: PF ratio \< 150, with PEEP/CPAP \> 5

You may not qualify if:

• r2 \< 0.95, monitored on the ventilator
• Expiratory flow that is not first-order or non-exponential decay
• Patients with Nor-epinephrine requirements \> 0.1 mcg/kg/min within 2 hours of intubation
• Patients requiring ECMO ( Extracorporeal membrane oxygenation)
• Patients with COPD or pulmonary fibrosis with a premorbid FEV1 \< 1.5 L
• Severe atherosclerotic vascular disease
• Patients with a chest tube, intra-abdominal hypertension or with its risk factors
• Patients with structural heart disease including pulmonary hypertension (RVSP \> 45) and heart failure
• All comfort care orders in the ICU
• Patients who underwent tracheostomy

Sponsors & Collaborators

• CentraCare: lead

Study Sites (1)

St Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

RECRUITING

Related Publications (2)

• Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.

  PMID: 34597688 BACKGROUND

• Guttmann J, Eberhard L, Fabry B, Bertschmann W, Zeravik J, Adolph M, Eckart J, Wolff G. Time constant/volume relationship of passive expiration in mechanically ventilated ARDS patients. Eur Respir J. 1995 Jan;8(1):114-20. doi: 10.1183/09031936.95.08010114.

  PMID: 7744177 BACKGROUND

Study Officials

• Ramakanth Pata, MD FCCP

  Centracare health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramakanth Pata, MD FCCP

CONTACT

320-240-2207; cookybrey1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 6, 2024
• Study Start: June 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (1)