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

NCT ID: NCT01825304

Last Updated: 2013-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS Intra-abdominal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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esophageal pressure ,titrated setting

Group Type ACTIVE_COMPARATOR

titrated setting peep

Intervention Type DEVICE

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

Group Type OTHER

titrated setting peep

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Gang Li

PLA Research Institute of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ventilator

Bern, Canton of Bern, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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li gang, master

Role: CONTACT

+86-025-80860066

Facility Contacts

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jiang fang zheng, doctor

Role: primary

(+86)025-8086437

Other Identifiers

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CC110-92

Identifier Type: -

Identifier Source: org_study_id

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