Physiological Studies in the Prone Position in Patients With ARDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Distress Syndrome, Mechanical Ventilation, Prone Positioning. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Respiratory Physiologic Efficacy of Prone Position and Its Association With Outcomes in ARDS: A Prospective Observational Cohort Study
Overview
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.
Primary outcome measures
- 28 days without mechanical ventilation [Time frame: From the date of enrollment to 28 days]
Secondary outcome measures (4)
- ICU mortality and in-hospital mortality [Time frame: From the date of enrollment until the date of discharge, assessed up to 1 year]
- Length of lCU stay and length of hospital stay [Time frame: From the date of enrollment until the date of discharge, assessed up to 1 year.]
- Respiratory physiological parameters. [Time frame: From enrollment to Day 7.]
- Indicators related to dead space [Time frame: From enrollment to Day 7.]
Eligibility criteria
Inclusion criteria
- Intubated patients
- Undergoing mechanical ventilation
- Moderate to severe ARDS
- Undergoing prone positioning
- Age≥18 years old
Exclusion criteria
- Pregnant
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Critical care medicine of West China Hospital — Chengdu
Identifiers
NCT: NCT06586736 · Prone position