Physiological Studies in the Prone Position in Patients With ARDS

NCT06586736 | Recruiting DMC

• 1 other identifier: Prone position
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Mechanical Ventilation; Prone Positioning

Keywords

Prone positioning; ARDS; Dead space ratio; Ventilatory ratio; Ventilation/perfusion

Outcome Measures

Primary Outcomes (1)

• 28 days without mechanical ventilation

  Days without mechanical ventilation support within 28 days after enrollment

  From the date of enrollment to 28 days

Secondary Outcomes (4)

• 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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Critical care medicine of West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Half a year after the publication of the research paper.
• Access Criteria: Any data collected during this study can be acquired from the correspondingauthor upon a reasonable request.

Locations

CN (1)