Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
NCT Number: NCT06430554
This observational study will explore the effects of PEEP and position on regional lung ventilation-perfusion mismatch by electrical impedance tomography (EIT) in moderate-to-severe ARDS patients with different lung recruitability.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Nanjing, Jiangsu, 210009, China
Location status: Recruiting
Acute respiratory distress syndrome (ARDS) is characterized by impaired ventilation-perfusion matching, which not only indicates the severity of the condition but also contributes to ventilation-induced lung injury. Higher positive end-expiratory pressure (PEEP) and prone position could improve ventilation-perfusion mismatch by recruiting collapsed lungs and facilitating more homogeneous ventilation, but these benefits might depend on lung recruitability. The present study aims to elucidate the regional effect of PEEP(low and high) and body position(supine and prone) on the ventilation-perfusion matching. Also endeavors to establish correlations between alterations in ventilation-perfusion matching patterns and the inherent lung recruitability.
Participants will be deeply sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH). Then the patients will be sequentially assigned to each of four conditions as follows:
Low PEEP, supine position; High PEEP, supine position; Low PEEP, prone position; High PEEP, prone position. High PEEP and low PEEP is defined as 15 cmH2O and 5 cmH2O (or airway opening pressure, either of which was higher) respectively. Each measurement (e.g., arterial blood gas analysis, respiratory parameters, hemodynamics, EIT measurements) will be performed at least 15 minutes after changing ventilator settings and at least 1 hour after changing body positions. The timing of turning patients from supine to prone position is determined by the clinical team.
To assess lung recruitability, a single-breath derecruitment maneuver will be performed by changing PEEP 15 to 5 cmH2O (or airway opening pressure, either of which was higher) in supine position. Patients with recruitment-inflation ratio over the median value are defined as high recruiters.
EIT data will be collected by standard device (Infinity C500, Drager, Germany) with a sample rate of 50 Hz. The EIT belt will be placed directly below the armpits, between the third and fifth intercostal spaces. This positioning of the EIT belt will be maintained consistently during both supine and prone positions. A bolus of 10 ml 5% NaCl will be injected during a respiratory pause (≥8 s) through the central venous catheter to assess lung ventilation and perfusion distributions. The primary endpoint is EIT-based ventilation-perfusion matching (V/Q match%).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion (within 24 hours)
corresponding to the pixels that are both ventilated and perfused divided by the total number of pixels ventilated and/or perfused
Time frame: Through study completion (within 24 hours)
corresponding to the ventilated but nonperfused pixels divided by the total number of pixels ventilated and/or perfused
Time frame: Through study completion (within 24 hours)
corresponding to the perfused but nonventilated pixels divided by the total number of pixels ventilated and/or perfused
Time frame: Through study completion (within 24 hours)
The compliance of respiratory system
Time frame: Through study completion (within 24 hours)
PaO2/FiO2 ratio
Contact information is provided by the study sponsor or research team.
Fengmei Guo, PhD, MD
CONTACT
Zhiqian Zha, MM
CONTACT
Zhongda Hospital
Other
Personalized Ventilatory Strategy Based on Ventilation-perfusion Mismatch and Lung Recruitability in Moderate-to-severe ARDS Patients
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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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