New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS

Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe acute respiratory distress syndrome (ARDS). But how to choose mechanical ventilation strategy is still not clear for severe ARDS patients supported by ECMO. Our previous work found that, compared to the traditional "lung rest" strategy, transpulmonary pressure guide new lung ventilation strategy can better maintain lung volume reduction lung collapse, atelectasis occurs. The severe ARDS patients receiving ECMO therapy were randomized divided into a new ventilation strategy group and the conventional ventilation strategy group. The new ventilation strategy is transpulmonary pressure guide ventilator setting method, and the conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide ventilation method. Compare the difference between the two groups of patients in lung injury, and explore the lung protection mechanism of new lung ventilation strategies guided by transpulmonary pressure. Our research group considered that transpulmonary pressure guide new lung ventilation strategy can provide more effective lung protection. And it will be further used in clinical work.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Device: New lung ventilation strategy; Device: Conventional ventilation strategy

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Chao-Yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ARDS cause reversible;
• Pure oxygen is given, but PaO2/FiO2<80;
• P(A-a)O2>600mmHg;
• Murray score≥3.0;
• pH<7.2;

Exclusion Criteria:

• peak inspiratory pressure>30cmH2O;
• high FiO2>0.8;
• ventilation>7 days;
• contraindication to heparinization;
• non-reversible central nervous system injury
• chronic disease with a short life expectancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Strategy; New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients	Device: New lung ventilation strategy; New ventilation strateg: pressure assist control mode; inspiratory pressure was lowered to keep Ppeak less than 25cmH2O; set the PEEP at such a level that expiratory transpulmonary pressure stays between 0 and 5 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.
Other: Conventional Strategy; Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients	Device: Conventional ventilation strategy; Conventional ventilation strategy: pressure assist control mode; keep the Ppeak between 20 and 25 cmH2O; set PEEP between 10 and 15 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion weaned from VV-ECMO	Respiratory failure was alleviated and then ECMO withdrawal could be considered	After patients randomized grouping 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60-day mortality	Mortality after patients randomized grouping 60 days	After patients randomized grouping 60 days

Collaborators and Investigators

• Sponsor: Rui Wang
• Investigators: Principal Investigator: Bing Sun, master, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): June 25, 2020
• Study Completion (Actual): June 25, 2020

Study Registration Dates

• First Submitted: May 1, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Extracorporeal Membrane Oxygenation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2014-KE-143