NCT03341572

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

November 13, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

November 8, 2017

Last Update Submit

November 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • CVP

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

    half an hour

Study Arms (2)

high response group

EXPERIMENTAL

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

low response group

PLACEBO COMPARATOR

the change of CVP is less than 2.5cmH2O

Other: 5,10 and 15cmH2O positive end expiratory pressure

Interventions

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

high response grouplow response group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with mechanical ventilation and inserted central venous line

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

SepsisBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • yi yang, doctor

    Zhongda Hospital

    STUDY CHAIR

Central Study Contacts

chenglong liang, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 14, 2017

Study Start

November 13, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations