Clinical trial NCT06827184: By Assessing the Continuous Respiratory Physiological Changes Through Prone Position, Determine the Optimal Duration for Prone Position
Official title: By Assessing the Continuous Respiratory Physiological Changes Through Prone Position, Determine the Optimal Duration for Prone Position
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Prone Position
Electrical Impedance Tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study focuses on patients with severe acute respiratory distress syndrome undergoing prone position therapy.

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.

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

Primary outcomes:
measure: Prone response
timeFrame: During the prone position(5 days)
Secondary outcomes:
measure: 28-day mortality
timeFrame: On the 28th day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ting-Yu Liao, MD
role: PRINCIPAL_INVESTIGATOR
References: