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

Recruiting

• Conditions: Acute Respiratory Distress Syndrome; Prone Position; Electrical Impedance Tomography

• Registration Number: NCT06827184
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2024-09-20
• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19
• Primary Completion: 2030-08-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prone response	During the prone position(5 days)	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

Secondary Outcome Measures

Name	Time	Method
28-day mortality	On the 28th day	The mortality status on the 28th day

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan