Impact of Positive End-expiratory Pressure on Hepatic Venous Flow
Impact of Moderate Positive End-expiratory Pressure on Hepatic Venous Flow in Patients Undergoing Cardiac Surgery
1 other identifier
interventional
15
0 countries
N/A
Brief Summary
The purpose of this study is to determine the difference in the impact of moderate positive end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac surgery: conventional versus protective ventilation strategy The possible changes in forward and backward flows (Doppler profiles) of hepatic venous flow at different degrees of PEEP in conventional and protective ventilation strategies are analyzed by using intraoperative transesophageal echocardiography (TEE) in patients undergoing cardiac surgery .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMarch 7, 2016
March 1, 2016
1 month
February 23, 2016
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
forward hepatic venous flow
Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
3 min after intervention
Secondary Outcomes (1)
reversed hepatic venous flow
3 min after intervention
Study Arms (4)
low PEEP conventional ventilation
ACTIVE COMPARATORPEEP 2 mmHg tidal volume 10ml/kg
moderate PEEP conventional ventilation
EXPERIMENTALPEEP 7 mmHg tidal volume 10ml/kg
low PEEP protective ventilation
EXPERIMENTALPEEP 2 mmHg with tidal volume 6 ml/kg
moderate PEEP protective ventilation
EXPERIMENTALPEEP 7 mmHg tidal volume 6ml/kg
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing cardiac surgery
- Patients provide written informed consents
You may not qualify if:
- Re-do or tri-do surgery
- Patients with active infection
- Patients with endocrine disease
- Patients ischemic heart disease
- patients with tricuspid valve regurgitation greater than mild degree
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
February 23, 2016
First Posted
March 7, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2016
Study Completion
May 1, 2016
Last Updated
March 7, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share