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

NCT ID: NCT06827184

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2030-12-31

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.

Conditions

Acute Respiratory Distress Syndrome; Prone Position; Electrical Impedance Tomography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Electrical Impedance Tomography

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

National Taiwan University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting-Yu Liao, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ting-Yu Liao, MD

Role: CONTACT

tingyuliao@ntuh.gov.tw

+886 2 23123456

Facility Contacts

Ting-Yu Liao, MD

Role: primary

tingyuliao@ntuh.gov.tw

+886 2 23123456

Other Identifiers

202310137DIND

Identifier Type: -

Identifier Source: org_study_id