Effect of PP in Patients With Ultra-low VT

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Physiological Effect of Prone Position in Patients With Ultra-low Tidal Volume Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215209
• Other study ID #: Ultra-low VT and PP
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Prone Position
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Tidal Volume

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