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Lung Alveolar Recruitment and Individualized PEEP Setting in Patients With ARDS

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ClinicalTrials.gov Identifier: NCT02361398
Recruitment Status : Recruiting
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by the highest on oxygenation and by lung electrical impedance tomography(EIT) on survival in subjects with severe Acute Respiratory Distress Syndrome(ARDS).

Condition or disease Intervention/treatment Phase
the PEEP Setting of ARDS Other: the EIT guide the individualized PEEP Setting Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lung Alveolar Recruitment and Individualized Positive End Expiratory Pressure(PEEP) Setting in Patients With Acute Respiratory Distress Syndrome(ARDS)
Study Start Date : January 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: EIT group
the Individualized PEEP titration by EIT was administered to the patients in the EIT group.
Other: the EIT guide the individualized PEEP Setting
the EIT guide the individualized PEEP Setting in the EIT group

No Intervention: oxygenation group
If patients are assigned to the oxygenation group, the Individualized PEEP Setting was by the best oxygenation as in the routines of the institution



Primary Outcome Measures :
  1. survival [ Time Frame: 28-day ]

Secondary Outcome Measures :
  1. length of ICU stay and hospital stay [ Time Frame: 28days ]
  2. pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; [ Time Frame: 7days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Moderate/ severe acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)>200 mmHg and PEEP >5cmH2O according to the the Berlin definition
  2. Body mass index < 40
  3. Written inform consent

Exclusion:

  1. pregnant ,intracranial hypertension,barotrauma
  2. left ventricular dysfunction (EF<30% )
  3. Patients with end-stage conditions(death expected within 90 days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361398


Contacts
Contact: Yun Long, MD 86-010-69152300 ly_icu@aliyun.com
Contact: He huaiwu, MM 86-010-69152300 tjmuhhe@163.com

Locations
China, Beijing
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Recruiting
Beijing, Beijing, China, 100730
Contact: Long Yun, MD         
Principal Investigator: Long Yun, MD         
Sub-Investigator: Huaiwu He, MM         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Director: Liu Dawei, MD Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02361398     History of Changes
Other Study ID Numbers: PUMCH-ARDS-EIT
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders