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Clinical Trials/NCT06215209
NCT06215209
Recruiting
Not Applicable

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

Southeast University, China1 site in 1 country45 target enrollmentStarted: February 20, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Southeast University, China
Enrollment
45
Locations
1
Primary Endpoint
ventilation-perfusion mathching

Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

ventilation-perfusion mathching

Time Frame: 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 Outcomes

  • The percentage of dead space(up to 24 hours)
  • The percentage of dorsal perfusion(up to 24 hours)
  • Arterial blood gas analysis(up to 24 hours)
  • The percentage of dorsal ventilation(up to 24 hours)
  • Center of ventilation (CoV)(up to 24 hours)
  • The percentage of shunt(up to 24 hours)
  • Regional ventilation delay (RVD)(up to 24 hours)
  • Respiratory system compliance(up to 24 hours)

Investigators

Sponsor
Southeast University, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ling Liu

Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Southeast University, China

Study Sites (1)

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