Effect of PP in Patients With Ultra-low VT

April 28, 2024 updated by: Ling Liu, Southeast University, China

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ultra-low tidal volume group
ARDS patients with ultra-low tidal volume ventilation
Other: position
patients will be in supine position and prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of shunt
Time Frame: 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
up to 24 hours
The percentage of dead space
Time Frame: 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
up to 24 hours
The percentage of dorsal ventilation
Time Frame: 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
up to 24 hours
The percentage of dorsal perfusion
Time Frame: 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
up to 24 hours
Center of ventilation (CoV)
Time Frame: 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
up to 24 hours
Regional ventilation delay (RVD)
Time Frame: 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
up to 24 hours
Arterial blood gas analysis
Time Frame: up to 24 hours
Arterial blood gas analysis included pH, PaO2, PaCO2 and PaO2/FiO2 in supine position and prone position
up to 24 hours
Respiratory system compliance
Time Frame: up to 24 hours
Respiratory system compliance will be monitored in supine position and prone position.
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Study Chair: liu ling, phD, Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ultra-low VT and PP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Distress Syndrome

Clinical Trials on position

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe