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RecruitingNCT06586736Updated Mar 3, 2025

Physiological Studies in the Prone Position in Patients With ARDS

An observational study in Acute Respiratory Distress Syndrome, Mechanical Ventilation and Prone Positioning, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-03-03.

Sponsored by West China Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
  • Mechanical Ventilation
  • Prone Positioning

Keywords

  • Prone positioning
  • ARDS
  • Dead space ratio
  • Ventilatory ratio
  • Ventilation/perfusion
03

In context

Respiratory Distress Syndrome

1,596 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

West China Hospital is the lead sponsor of 484 studies on the registry; 241 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We conducted a prospective cohort study in a intensive care unit in West China Hospital, Sichuan University, China. Adult patients (age≥18years) who were diagnosed with moderate to severe ARDS according to the Berlin definition, received mechanical ventilation and prone positioning were included.

Inclusion criteria

  1. Intubated patients
  2. Undergoing mechanical ventilation
  3. Moderate to severe ARDS
  4. Undergoing prone positioning
  5. Age≥18 years old

Exclusion criteria

Exclusion Criteria:

  1. Pregnant
  2. Cardiac structural shunt
  3. Extracorporeal membrane oxygenation performed
  4. Undergo extracorporeal CO2 removal
  5. Pulmonary embolism
  6. Other situation that may affect the accuracy of PetCO2 monitoring
  7. Prone positioning session less than 10 hours
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 28 days without mechanical ventilation

    Days without mechanical ventilation support within 28 days after enrollment

    Time frame: From the date of enrollment to 28 days

Secondary outcomes

  1. ICU mortality and in-hospital mortality

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

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

  2. Length of lCU stay and length of hospital stay

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

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

  3. Respiratory physiological parameters.

    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。

    Time frame: From enrollment to Day 7.

  4. Indicators related to dead space

    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

    Time frame: From enrollment to Day 7.

07

Study locations

1 of 1 sites recruiting
  • Department of Critical care medicine of West China Hospital
    Chengdu, Sichuan 610041, China
    • Y F zhou, MM · Contact · zyfmg@163.com · 8613880012276
    • Y Y Yang, MM · Contact · 942430456@qq.com · 8615208341257
    • Y F Zhou, MM · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Any data collected during this study can be acquired from the correspondingauthor upon a reasonable request.

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06586736
Lead sponsor
West China Hospital
Responsible party
Zhou Yongfang (Principal Investigator, West China Hospital) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 1, 2023
Primary completion
Jun 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Mar 3, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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