Effect of PP in Patients With Ultra-low VT

NCT06215209 | Recruiting

• 1 other identifier: Ultra-low VT and PP
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Prone Position; Tidal Volume

Outcome Measures

Primary Outcomes (1)

• ventilation-perfusion mathching

  ventilation-perfusion matching will be monitored using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany) in supine position and prone position

  up to 24 hours

Secondary Outcomes (8)

• The percentage of shunt

  up to 24 hours

• The percentage of dead space

  up to 24 hours

• The percentage of dorsal ventilation

  up to 24 hours

• The percentage of dorsal perfusion

  up to 24 hours

• Center of ventilation (CoV)

  up to 24 hours

Study Arms (1)

ultra-low tidal volume group

ARDS patients with ultra-low tidal volume ventilation

Other: position

Interventions

position OTHER

patients will be in supine position and prone position

ultra-low tidal volume group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Adult patients were enrolled if they were undergoing invasive mechanical ventilation and were supported by VV-ECMO for less than 48 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• liu ling, phD

  Zhongda Hospital

  STUDY CHAIR

Central Study Contacts

liu ling, phD

CONTACT

025-83262550; liulingdoctor@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: February 20, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)