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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01825304
• Other study ID #: CC110-92
• Status: Recruiting
• Phase: Phase 4
• First received: April 2, 2013
• Last updated: April 4, 2013
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: October 2011
• Source: Nanjing Medical University
• Contact: li gang, master
• Phone: +86-025-80860066
• Email: leeg871027[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ARDS
• Hypertension
• Intra-Abdominal Hypertension

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Ventilator	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	Jinling Hospital, China

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	mortality	28-Day mortality include patients who giving up treatment due to critical condition	28d	Yes