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NCT Number: NCT06827184

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

electrical impedance tomography

Device

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

Primary outcomes

  1. Prone response

    Time frame: 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 outcomes

  1. 28-day mortality

    Time frame: On the 28th day

    The mortality status on the 28th day

Study contacts

Contact information is provided by the study sponsor or research team.

Ting-Yu Liao, MD

CONTACT

[email protected]

+886 2 23123456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 14, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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