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

NCT06827184 | Recruiting FDA Device

• 1 other identifier: 202310137DIND
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome; Prone Position; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 28-day mortality

  On the 28th day

Interventions

Electrical Impedance Tomography DEVICE

It utilizes electrical impedance tomography to analyze a series of physiological changes in the lungs following treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ting-Yu Liao, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Yu Liao, MD

CONTACT

+886 2 23123456; tingyuliao@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: September 20, 2024
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)