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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06827184
Enrollment
100
Registered
2025-02-14
Start date
2024-09-20
Completion date
2030-12-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Electrical Impedance Tomography, Prone Position

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.

Interventions

DEVICEElectrical Impedance Tomography

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prone responseDuring 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

MeasureTime frameDescription
28-day mortalityOn the 28th dayThe mortality status on the 28th day

Countries

Taiwan

Contacts

Primary ContactTing-Yu Liao, MD
tingyuliao@ntuh.gov.tw+886 2 23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026