By Assessing the Continuous Respiratory Physiological Changes Through Prone Position, Determine the Optimal Duration for Prone Position

The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Prone Position; Electrical Impedance Tomography
• Intervention / Treatment: Device: Electrical Impedance Tomography

Detailed Description

The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.

Therefore, the investigators propose a project with the aim of collecting relevant clinical, laboratory, imaging, and respiratory physiology data from consenting patients with ARDS within the study period. The objective is to analyze changes in biomarkers following prone position.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ting-Yu Liao, MD; Phone Number: +886 2 23123456; Email: tingyuliao@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Ting-Yu Liao, MD; Phone Number: +886 2 23123456; Email: tingyuliao@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study focuses on patients with severe acute respiratory distress syndrome undergoing prone position therapy.

Description

Inclusion Criteria:

1. Acute respiratory distress syndrome
2. Age > 18
3. Serial arterial blood gas data：PaO2/FiO2 <150. The mechanical ventilator setting：FiO2>0.6, PEEP>5 cmH2O

Exclusion Criteria:

1. Implantable electronic devices (e.g., pacemakers)
2. Body mass index > 30
3. Major thoracic and abdominal surgery
4. Patients with unstable spine and pelvis conditions
5. Pregnant women in the second and third trimesters
6. Patients with head trauma, elevated intracranial pressure, or elevated intraocular pressure
7. Hemodynamically unstable patients unsuitable for prone ventilation therapy
8. Patients with active seizures

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prone response	Responder is defined as an increase in PaO2 by 20 mmHg or an increase in PaO2/FiO2 by 20% one hour after receiving prone position therapy	During the prone position(5 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	The mortality status on the 28th day	On the 28th day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ting-Yu Liao, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 202310137DIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes