NCT01825304

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 5, 2013

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

April 2, 2013

Last Update Submit

April 4, 2013

Conditions

ARDSIntra-abdominal Hypertension

Keywords

mechanical ventilationIntra-abdominal hypertensionpositive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

  • 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.

    28d

Secondary Outcomes (1)

  • mortality

    28d

Study Arms (2)

esophageal pressure ,titrated setting

ACTIVE COMPARATOR
Device: titrated setting peep

ARDSNet recommendations,peep

OTHER
Device: titrated setting peep

Interventions

titrated setting peepDEVICE

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

ARDSNet recommendations,peepesophageal pressure ,titrated setting

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • intra-abdominal hypertension
  • mechanical ventilation
  • sedation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ventilator

Bern, Canton of Bern, CH-7402, Switzerland

RECRUITING

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

li gang, master

CONTACT

+86-025-80860066leeg871027@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PLA Research Institute of general surgery

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 5, 2013

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

April 5, 2013

Record last verified: 2011-10

Locations

CH(1)