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

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

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 Overview

• Status: Unknown
• Conditions: ARDS; Intra-abdominal Hypertension
• Intervention / Treatment: Device: titrated setting peep

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, CH-7402
    • Recruiting
    • Ventilator
    • Contact: jiang fang zheng, doctor; Phone Number: (+86)025-8086437; Email: shuhj1987@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	28-Day mortality include patients who giving up treatment due to critical condition	28d

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Estimate): April 5, 2013
• Last Update Submitted That Met QC Criteria: April 4, 2013
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: mechanical ventilation; positive end-expiratory pressure; Intra-abdominal hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Hypertension; Intra-Abdominal Hypertension
• Other Study ID Numbers: CC110-92