Clinical trial NCT06215209: Effect of PP in Patients With Ultra-low VT
Official title: Physiological Effect of Prone Position in Patients With Ultra-low Tidal Volume Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Prone Position
Tidal Volume
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with ARDS admitted to the Department of Critical Care Medicine, Zhongda Hospital, Southeast University and receiving VV-ECMO treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: ventilation-perfusion mathching
timeFrame: up to 24 hours
Secondary outcomes:
measure: The percentage of shunt
timeFrame: up to 24 hours
measure: The percentage of dead space
timeFrame: up to 24 hours
measure: The percentage of dorsal ventilation
timeFrame: up to 24 hours
measure: The percentage of dorsal perfusion
timeFrame: up to 24 hours
measure: Center of ventilation (CoV)
timeFrame: up to 24 hours
measure: Regional ventilation delay (RVD)
timeFrame: up to 24 hours
measure: Arterial blood gas analysis
timeFrame: up to 24 hours
measure: Respiratory system compliance
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: liu ling, phD
role: STUDY_CHAIR
References: