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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southeast University, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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