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

NCT02439151 | Completed DMC

• 1 other identifier: 2014-KE-143
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Extracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

• Proportion weaned from VV-ECMO

  Respiratory failure was alleviated and then ECMO withdrawal could be considered

  After patients randomized grouping 60 days

Secondary Outcomes (1)

• 60-day mortality

  After patients randomized grouping 60 days

Study Arms (2)

New Strategy

EXPERIMENTAL

New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients

Device: New lung ventilation strategy

Conventional Strategy

OTHER

Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients

Device: Conventional ventilation strategy

Interventions

New lung ventilation strategy DEVICE

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.

New Strategy

Conventional ventilation strategy DEVICE

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.

Conventional Strategy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rui Wang: lead

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Bing Sun, master

  Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

CN (1)