The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance

• Sponsor: Jingyuan,Xu (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03341572
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 1.5
• Patients Per Site Per Month: 19.4

Study Details

Study Description

Brief Summary

To observe the effect of PEEP on CVP among patients with different respiratory compliance

Condition or Disease	Intervention/Treatment	Phase
Sepsis; ARDS; Traumatic Brain Injury	Other: 5,10 and 15cmH2O positive end expiratory pressure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Positive End Expiratory Pressure on Central Venous Pressure Among Patients With Different Lung Compliance
• Anticipated Study Start Date: Nov 13, 2017
• Anticipated Primary Completion Date: Dec 30, 2017
• Anticipated Study Completion Date: Dec 30, 2017

Arms and Interventions

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	Other: 5,10 and 15cmH2O positive end expiratory pressure; 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	Other: 5,10 and 15cmH2O positive end expiratory pressure; every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points

Outcome Measures

Primary Outcome Measures

1. CVP [half an hour]

   Measure the central venous pressure of the three level PEEPs of 5,10 and 15cmH2O.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with mechanical ventilation and inserted central venous line

Exclusion Criteria:

1. The age is less than 18 years old or more than 80 years old；

2. Pregnant and lying-in woman；

3. Patients undergoing fluid resuscitation and the speed is more than 200ml/h；

4. Patients with norepinephrine dose are greater than 15 micro per minute；

5. Patients with pericarditis、pulmonary heart disease、right heart failure、atrial fibrillation；

6. Patients with COPD(endogenous PEEP is more than 2cmH2O)、tension pneumonthorax、acute episode asthma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongda Hospital	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• Jingyuan,Xu

Investigators

• Study Chair: yi yang, doctor, Zhongda Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jingyuan,Xu, Attending doctor, Southeast University, China
• ClinicalTrials.gov Identifier: NCT03341572
• Other Study ID Numbers: 2017ZDSYLL094-P01
• First Posted: Nov 14, 2017
• Last Update Posted: Nov 14, 2017
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

No Results Posted as of Nov 14, 2017