- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341572
The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
November 13, 2017 updated by: Jingyuan,Xu
To observe the effect of PEEP on CVP among patients with different respiratory compliance
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Recruiting
- Zhongda Hospital
-
Principal Investigator:
- chenglong liang, master
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: high response group
patients undergo 5,10 and 15cmH2O positive end expiratory pressure ,the change of central venous pressure is more than 2.5cmH2O
|
every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points
|
|
PLACEBO_COMPARATOR: low response group
the change of CVP is less than 2.5cmH2O
|
every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CVP
Time Frame: half an hour
|
Measure the central venous pressure of the three level PEEPs of 5,10 and 15cmH2O.
|
half an hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: yi yang, doctor, Zhongda Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 13, 2017
Primary Completion (ANTICIPATED)
December 30, 2017
Study Completion (ANTICIPATED)
December 30, 2017
Study Registration Dates
First Submitted
November 8, 2017
First Submitted That Met QC Criteria
November 13, 2017
First Posted (ACTUAL)
November 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 13, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017ZDSYLL094-P01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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