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Clinical Trials/NCT06586736
NCT06586736
Recruiting
Not Applicable

The Respiratory Physiologic Efficacy of Prone Position and Its Association With Outcomes in ARDS: A Prospective Observational Cohort Study

West China Hospital1 site in 1 country100 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
West China Hospital
Enrollment
100
Locations
1
Primary Endpoint
28 days without mechanical ventilation
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to observe the changes of physiological indicators such as ventilation and oxygenation in the prone position of ARDS patients, to observe the change trend of each patient's indicators, and to observe whether different trends of indicators predict different prognosis of patients.

Detailed Description

PP has been shown to effectively improve the prognosis of patients with severe ARDS, but not all patients with ARDS can benefit from PP, and the implementation of the PP has a certain clinical risks and side effects, we lack a convenient predictors to guide doctors to determine whether patients should implement the PP. Clinical usually observe the P/F improved as whether PP treatment effective reference, but there are literature points out that the rising P/F after PP can not predict the better prognosis. one of the mechanisms for ARDS patients benefit from PP is proved to be improve V/Q, the change of the V/Q may determine whether the PP treatment effectively is an important indicator. PaO2:FiO2 ratio was usually used to evaluate the effect of PP, but some studies did not support this conclusion. PP has been shown to change ventilation-perfusion ratio, dead space may be better physiological indicators, simplify dead space ratio and Ventilatory ratio can be easily accessed at bedside and is associated with mortality of patients with ARDS. The purpose of this study is to observe the predictive value of P/F, VD-etCO2/VT, and VR on the treatment effect of ARDS undergoing PP.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
June 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhou Yongfang

Principal Investigator

West China Hospital

Eligibility Criteria

Inclusion Criteria

  • Intubated patients
  • Undergoing mechanical ventilation
  • Moderate to severe ARDS
  • Undergoing prone positioning
  • Age≥18 years old

Exclusion Criteria

  • Cardiac structural shunt
  • Extracorporeal membrane oxygenation performed
  • Undergo extracorporeal CO2 removal
  • Pulmonary embolism
  • Other situation that may affect the accuracy of PetCO2 monitoring
  • Prone positioning session less than 10 hours

Outcomes

Primary Outcomes

28 days without mechanical ventilation

Time Frame: From the date of enrollment to 28 days

Days without mechanical ventilation support within 28 days after enrollment

Secondary Outcomes

  • ICU mortality and in-hospital mortality(From the date of enrollment until the date of discharge, assessed up to 1 year)
  • Length of lCU stay and length of hospital stay(From the date of enrollment until the date of discharge, assessed up to 1 year.)
  • Respiratory physiological parameters.(From enrollment to Day 7.)
  • Indicators related to dead space(From enrollment to Day 7.)

Study Sites (1)

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