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

Sponsor

Rui Wang (Other)

Overall Status

Completed

CT.gov ID

NCT02439151

Collaborator

(none)

104

Enrollment

Location

Arms

61.8

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult	Device: New lung ventilation strategy Device: Conventional ventilation strategy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Jun 25, 2020

Actual Study Completion Date :

Jun 25, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion weaned from VV-ECMO [After patients randomized grouping 60 days]
Respiratory failure was alleviated and then ECMO withdrawal could be considered

Secondary Outcome Measures

60-day mortality [After patients randomized grouping 60 days]
Mortality after patients randomized grouping 60 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chao-Yang Hospital	Beijing	Beijing	China	100020

Sponsors and Collaborators

Rui Wang

Investigators

Principal Investigator: Bing Sun, master, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rui Wang, Principal Investigator, Beijing Chao Yang Hospital

ClinicalTrials.gov Identifier:

NCT02439151

Other Study ID Numbers:

2014-KE-143

First Posted:

May 8, 2015

Last Update Posted:

Jul 1, 2020

Last Verified:

Jun 1, 2020

Keywords provided by Rui Wang, Principal Investigator, Beijing Chao Yang Hospital

Extracorporeal Membrane Oxygenation

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Study Results

No Results Posted as of Jul 1, 2020