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The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT01825304
Recruitment Status : Unknown
Verified October 2011 by Gang Li, Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : April 5, 2013
Last Update Posted : April 5, 2013
Sponsor:
Collaborator:
Jinling Hospital, China
Information provided by (Responsible Party):
Gang Li, Nanjing Medical University

Brief Summary:
Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung injury/acute respiratory distress syndrome will appear. In the group of people who suffering intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of ALI/ARDS, which may decrease morbidity in this population.

Condition or disease Intervention/treatment Phase
ARDS Intra-abdominal Hypertension Device: titrated setting peep Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: the Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
Study Start Date : October 2011
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: esophageal pressure ,titrated setting Device: titrated setting peep
titrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group.

ARDSNet recommendations,peep Device: titrated setting peep
titrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group.




Primary Outcome Measures :
  1. ventilator-free days [ Time Frame: 28d ]
    Comparison of two groups the duration of ventilation-free in 28d,ventilator-free day include weaning from mechanical ventilation more than 24h.


Secondary Outcome Measures :
  1. mortality [ Time Frame: 28d ]
    28-Day mortality include patients who giving up treatment due to critical condition



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • intra-abdominal hypertension
  • mechanical ventilation
  • sedation

Exclusion Criteria:

  • underlying pulmonary disease
  • age older than 60 years and younger than 18 years
  • vital signs were not stable
  • non voluntary

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): NCT01825304


Contacts
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Contact: li gang, master +86-025-80860066 leeg871027@163.com

Locations
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Switzerland
Ventilator Recruiting
Bern, Switzerland, CH-7402
Contact: jiang fang zheng, doctor    (+86)025-8086437    shuhj1987@sina.com   
Sponsors and Collaborators
Nanjing Medical University
Jinling Hospital, China

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Responsible Party: Gang Li, PLA Research Institute of general surgery, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01825304     History of Changes
Other Study ID Numbers: CC110-92
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: October 2011
Keywords provided by Gang Li, Nanjing Medical University:
mechanical ventilation
Intra-abdominal hypertension
positive end-expiratory pressure
Additional relevant MeSH terms:
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Intra-Abdominal Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Compartment Syndromes
Muscular Diseases
Musculoskeletal Diseases