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

• Sponsor: Nanjing Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01825304
• Collaborator: Jinling Hospital, China (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS; Intra-abdominal Hypertension	Device: titrated setting peep	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: the Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Jun 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. ventilator-free days [28d]

   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

1. mortality [28d]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ventilator	Bern		Switzerland	CH-7402

Sponsors and Collaborators

• Nanjing Medical University
• Jinling Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gang Li, PLA Research Institute of general surgery, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT01825304
• Other Study ID Numbers: CC110-92
• First Posted: Apr 5, 2013
• Last Update Posted: Apr 5, 2013
• Last Verified: Oct 1, 2011

• Keywords provided by Gang Li, PLA Research Institute of general surgery, Nanjing Medical University: mechanical ventilation; Intra-abdominal hypertension; positive end-expiratory pressure
• Additional relevant MeSH terms: Intra-Abdominal Hypertension; Hypertension

Study Results

No Results Posted as of Apr 5, 2013