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NCT Number: NCT06586736

Physiological Studies in the Prone Position in Patients With ARDS

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. ICU mortality and in-hospital mortality

    Time frame: From the date of enrollment until the date of discharge, assessed up to 1 year

    Prognostic measures will be recorded until discharge, such as ICU mortality and in-hospital mortality

  2. 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.

    Prognostic measures will be recorded until discharge, such as length of lICU stay and length of hospital stay in days.

  3. Respiratory physiological parameters.

    Time frame: From enrollment to Day 7.

    Respiratory physiological parameters are collected at each time point (before prone positioning , every 4 hours after prone positioning, and 4 hours after turn back to supine position), such as PaO2/FiO2。

  4. Indicators related to dead space

    Time frame: From enrollment to Day 7.

    Indicators related to dead space are collected at each time point (before prone positioning , every 4 hours after prone positioning, and 4 hours after turn back to supine position), such as VR and dead space ratio, which were calculated by predicted body weight, partial pressure of carbon dioxide and end-tidal carbon dioxide

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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