Effect of PP in Patients With Ultra-low VT

Recruiting

• Conditions: Prone Position; Tidal Volume; Acute Respiratory Distress Syndrome
• Interventions: Other: position

• Registration Number: NCT06215209
• Lead Sponsor: Southeast University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-22
• Study Start: 2024-02-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-02-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ultra-low tidal volume group	position	ARDS patients with ultra-low tidal volume ventilation

Primary Outcome Measures

Name	Time	Method
ventilation-perfusion mathching	up to 24 hours	ventilation-perfusion matching will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position

Secondary Outcome Measures

Name	Time	Method
Center of ventilation (CoV)	up to 24 hours	Center of ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
The percentage of dead space	up to 24 hours	The percentage of shunt will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
The percentage of dorsal perfusion	up to 24 hours	The percentage of dorsal ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Arterial blood gas analysis	up to 24 hours	Arterial blood gas analysis included pH, PaO2, PaCO2 and PaO2/FiO2 in supine position and prone position
The percentage of dorsal ventilation	up to 24 hours	The percentage of dorsal ventilation will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
The percentage of shunt	up to 24 hours	The percentage of shunt will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Regional ventilation delay (RVD)	up to 24 hours	Regional ventilation delay will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position
Respiratory system compliance	up to 24 hours	Respiratory system compliance will be monitored in supine position and prone position.

Trial Locations

Locations (1)

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University; 🇨🇳 Nanjing, Jiangsu, China