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Clinical Trials/NCT01825304
NCT01825304UnknownPhase 4

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

Nanjing Medical University2 sites in 1 country60 target enrollmentStarted: October 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
ventilator-free days

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • intra-abdominal hypertension
  • mechanical ventilation

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • mortality(28d)

Investigators

Sponsor
Nanjing Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gang Li

PLA Research Institute of general surgery

Nanjing Medical University

Study Sites (2)

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