Recruiting

Observational Study

Sponsor:

CentraCare

Code:

NCT06400095

Conditions

ARDS

Mechanical Power

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Poccl, Time constant, driving pressure

Study Details

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

Study ID

NCT06400095

Start date

Jun 1, 2023

Status verified date

Aug, 2024

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Poccl, Time constant, driving pressure

Ventilatory parameters

Primary outcome measure

  • Survival or mortality [ Time Frame: From the date of enrollment to 90 days from enrolment or date of death, whichever came first, assessed up to 90 days. ]

Central Contacts and Locations

Central contacts

Ramakanth Pata, MD FCCP

320-240-2207cookybrey1@gmail.com

Locations

St Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

Contacts

Ramakanth Pata, MD FCCP

320-240-2207cookybrey1@gmail.com

More Information

Sponsor

CentraCare

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CentraCare on 2024-08-22.