Back to resultsThe Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
Primary Purpose
Sepsis, ARDS, Traumatic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
5,10 and 15cmH2O positive end expiratory pressure
Sponsored by
About this trial
This is an interventional supportive care trial for Sepsis
Eligibility Criteria
Inclusion Criteria:
1. Patients with mechanical ventilation and inserted central venous line
Exclusion Criteria:
- The age is less than 18 years old or more than 80 years old；
- Pregnant and lying-in woman；
- Patients undergoing fluid resuscitation and the speed is more than 200ml/h；
- Patients with norepinephrine dose are greater than 15 micro per minute；
- Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation；
- Patients with COPD(endogenous PEEP is more than 2cmH2O)、tension pneumonthorax、acute episode asthma
Sites / Locations
- Zhongda HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
high response group
low response group
Arm Description
patients undergo 5,10 and 15cmH2O positive end expiratory pressure ,the change of central venous pressure is more than 2.5cmH2O
the change of CVP is less than 2.5cmH2O
Outcomes
Primary Outcome Measures
CVP
Measure the central venous pressure of the three level PEEPs of 5,10 and 15cmH2O.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03341572
Brief Title
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
Official Title
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2017 (Anticipated)
Primary Completion Date
December 30, 2017 (Anticipated)
Study Completion Date
December 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jingyuan,Xu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To observe the effect of PEEP on CVP among patients with different respiratory compliance
Detailed Description
30 patients with mechanical ventilation and inserted central venous line will be entered. After gathering demographic data, patients undergone 5,10 and 15cmH2O PEEPs and the respective CVPs of the mentioned points will be recorded. According to the change of CVP, the patients will be divided into high response group and low response group, then comparing the lung compliance and thorax elastic resistance differences between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, ARDS, Traumatic Brain Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high response group
Arm Type
Experimental
Arm Description
patients undergo 5,10 and 15cmH2O positive end expiratory pressure ,the change of central venous pressure is more than 2.5cmH2O
Arm Title
low response group
Arm Type
Placebo Comparator
Arm Description
the change of CVP is less than 2.5cmH2O
Intervention Type
Other
Intervention Name(s)
5,10 and 15cmH2O positive end expiratory pressure
Intervention Description
every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points
Primary Outcome Measure Information:
Title
CVP
Description
Measure the central venous pressure of the three level PEEPs of 5,10 and 15cmH2O.
Time Frame
half an hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patients with mechanical ventilation and inserted central venous line
Exclusion Criteria:
The age is less than 18 years old or more than 80 years old；
Pregnant and lying-in woman；
Patients undergoing fluid resuscitation and the speed is more than 200ml/h；
Patients with norepinephrine dose are greater than 15 micro per minute；
Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation；
Patients with COPD(endogenous PEEP is more than 2cmH2O)、tension pneumonthorax、acute episode asthma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chenglong liang, master
Phone
15261893562
Email
15261893562@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
yi yang, doctor
Phone
+8602583262550
Email
yiyiyang2004@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yi yang, doctor
Organizational Affiliation
Zhongda Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chenglong liang, master
Phone
15261893562
Email
15261893562@163.com
First Name & Middle Initial & Last Name & Degree
yi yang, doctor
Phone
+8602583262550
Email
yiyiyang2004@163.com
First Name & Middle Initial & Last Name & Degree
chenglong liang, master
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
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