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

Primary Purpose

ARDS, Intra-abdominal Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
titrated setting peep
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS focused on measuring mechanical ventilation, Intra-abdominal hypertension, positive end-expiratory pressure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VentilatorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

esophageal pressure ,titrated setting

ARDSNet recommendations,peep

Arm Description

Outcomes

Primary Outcome Measures

ventilator-free days
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

mortality
28-Day mortality include patients who giving up treatment due to critical condition

Full Information

First Posted
April 2, 2013
Last Updated
April 4, 2013
Sponsor
Nanjing Medical University
Collaborators
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01825304
Brief Title
The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
Official Title
the Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
Collaborators
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Intra-abdominal Hypertension
Keywords
mechanical ventilation, Intra-abdominal hypertension, positive end-expiratory pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
esophageal pressure ,titrated setting
Arm Type
Active Comparator
Arm Title
ARDSNet recommendations,peep
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
titrated setting peep
Intervention Description
titrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group.
Primary Outcome Measure Information:
Title
ventilator-free days
Description
Comparison of two groups the duration of ventilation-free in 28d,ventilator-free day include weaning from mechanical ventilation more than 24h.
Time Frame
28d
Secondary Outcome Measure Information:
Title
mortality
Description
28-Day mortality include patients who giving up treatment due to critical condition
Time Frame
28d

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
li gang, master
Phone
+86-025-80860066
Email
leeg871027@163.com
Facility Information:
Facility Name
Ventilator
City
Bern
ZIP/Postal Code
CH-7402
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiang fang zheng, doctor
Phone
(+86)025-8086437
Email
shuhj1987@sina.com

12. IPD Sharing Statement

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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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