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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06215209
Other study ID # Ultra-low VT and PP
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2024
Est. completion date April 1, 2025

Study information

Verified date April 2024
Source Southeast University, China
Contact liu ling, phD
Phone 025-83262550
Email liulingdoctor@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute respiratory distress syndrome (ARDS) is a heterogeneous syndrome with similar clinicopathological feathers caused by different etiologies. Respiratory supportive strategies is the main ARDS management, and the guidelines recommend low tidal volume to improve clinical outcomes. To be note, overdistension can still occur even if using a tidal volume as low as 6 ml/kg, given the heterogeneous nature of the syndrome. Therefore, adjusting tidal volume level to less than 6ml/kg may reduce ventilator-induced lung injury (VILI) and thus improve outcomes, especially in patients with severe lung injury. Prone position is also an important management in severe ARDS. Prone position can improve ventilation-perfusion (V/Q) matching and reduce the risk of VILI by recruiting dorsal collapsed alveoli. Meanwhile, prone position has also been shown to improve hemodynamics. Recent studies have showed that prone position did not reduce duration of venovenous extracorporeal membrane oxygenation (VV-ECMO) and 90-day mortality in patients with ARDS who receive VV-ECMO with ultra-low tidal volume ventilation. Therefore, the effect of PP on ventilation and lung blood flow in ARDS patients treated with VV-ECMO wiht ultra-low tidal volume ventilation remains unclear.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date April 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Adult patients were enrolled if they were undergoing invasive mechanical ventilation and were supported by VV-ECMO for less than 48 hours Exclusion Criteria: - younger than 18 years old - contraindications for prone position ventilation - past chronic respiratory diseases (long-term family oxygen therapy for chronic - respiratory diseases such as pulmonary fibrosis or COPD) - New York Heart Association class above II - contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician) - severe hemodynamic instability - gave written or witnessed verbal informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
position
patients will be in supine position and prone position

Locations

Country Name City State
China Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ventilation-perfusion mathching ventilation-perfusion matching will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lu¨beck, Germany) in supine position and prone position up to 24 hours
Secondary The percentage of shunt The percentage of shunt will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lu¨beck, Germany) in supine position and prone position up to 24 hours
Secondary The percentage of dead space The percentage of shunt will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lu¨beck, Germany) in supine position and prone position up to 24 hours
Secondary The percentage of dorsal ventilation The percentage of dorsal ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lu¨beck, Germany) in supine position and prone position up to 24 hours
Secondary The percentage of dorsal perfusion The percentage of dorsal ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lu¨beck, Germany) in supine position and prone position up to 24 hours
Secondary Center of ventilation (CoV) Center of ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lu¨beck, Germany) in supine position and prone position up to 24 hours
Secondary Regional ventilation delay (RVD) Regional ventilation delay will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lu¨beck, Germany) in supine position and prone position up to 24 hours
Secondary Arterial blood gas analysis Arterial blood gas analysis included pH, PaO2, PaCO2 and PaO2/FiO2 in supine position and prone position up to 24 hours
Secondary Respiratory system compliance Respiratory system compliance will be monitored in supine position and prone position. up to 24 hours
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