Valvular Heart DiseaseNCT02700581
Impact of Positive End-expiratory Pressure on Hepatic Venous Flow
A study testing low PEEP conventional ventilation, moderate PEEP conventional ventilation and low PEEP protective ventilation in people with Valvular Heart Disease, run by Konkuk University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- low PEEP conventional ventilation, moderate PEEP conventional ventilation and low PEEP protective ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac surgery
- Patients provide written informed consents
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Moderate Positive End-expiratory Pressure on Hepatic Venous Flow in Patients Undergoing Cardiac Surgery
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 .
Read the detailed description
Following data would be determined after 5 min-exposure volume controlled ventilation employing tidal volume of 10 ml/kg and 6 ml/kg with low PEEP (with 2 mmHg) and moderate PEEP (7 mmHg) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=12)
- sum of forward hepatic venous flow
- sum of backward hepatic venous flow
- peak velocity of diastolic hepatic venous flow
- lung compliance
- peak airway pressure
- mean airway pressure
- other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary
- Conditions
- Valvular Heart Disease
- Being tested
- low PEEP conventional ventilation, moderate PEEP conventional ventilation, low PEEP protective ventilation, moderate PEEP protective ventilation
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low PEEP conventional ventilationProcedure or surgery
moderate PEEP conventional ventilationProcedure or surgery
low PEEP protective ventilationProcedure or surgery
moderate PEEP protective ventilationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| low PEEP conventional ventilation | Active comparator | PEEP 2 mmHg tidal volume 10ml/kg Receives: Procedure: low PEEP conventional ventilation |
| moderate PEEP conventional ventilation | Experimental | PEEP 7 mmHg tidal volume 10ml/kg Receives: Procedure: moderate PEEP conventional ventilation |
| low PEEP protective ventilation | Experimental | PEEP 2 mmHg with tidal volume 6 ml/kg Receives: Procedure: low PEEP protective ventilation |
| moderate PEEP protective ventilation | Experimental | PEEP 7 mmHg tidal volume 6ml/kg Receives: Procedure: moderate PEEP protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
forward hepatic venous flow
Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
Measured: 3 min after intervention
Secondary outcomes (1)
reversed hepatic venous flow
Reversed hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
Measured: 3 min after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700581
- Sponsor's protocol ID
- KUH000000 TBD
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2016
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Moderate Positive End-expiratory Pressure on Hepatic Venous Flow in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02700581
- Acronym / sponsor ID
- KUH000000 TBD
- Conditions
- Valvular Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Following data would be determined after 5 min-exposure volume controlled ventilation employing tidal volume of 10 ml/kg and 6 ml/kg with low PEEP (with 2 mmHg) and moderate PEEP (7 mmHg) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=12)
- sum of forward hepatic venous flow
- sum of backward hepatic venous flow
- peak velocity of diastolic hepatic venous flow
- lung compliance
- peak airway pressure
- mean airway pressure
- other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low PEEP conventional ventilation | Active comparator | Procedure: low PEEP conventional ventilationPEEP 2 mmHg tidal volume 10ml/kg |
| moderate PEEP conventional ventilation | Experimental | Procedure: moderate PEEP conventional ventilationPEEP 7 mmHg tidal volume 10ml/kg |
| low PEEP protective ventilation | Experimental | Procedure: low PEEP protective ventilationPEEP 2 mmHg with tidal volume 6 ml/kg |
| moderate PEEP protective ventilation | Experimental | Procedure: moderate PEEP protective ventilationPEEP 7 mmHg tidal volume 6ml/kg |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing cardiac surgery
- Patients provide written informed consents
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low PEEP conventional ventilation | Procedure or surgery | low PEEP conventional ventilation |
| moderate PEEP conventional ventilation | Procedure or surgery | moderate PEEP conventional ventilation |
| low PEEP protective ventilation | Procedure or surgery | low PEEP protective ventilation |
| moderate PEEP protective ventilation | Procedure or surgery | moderate PEEP protective ventilation |
Primary outcome
forward hepatic venous flow
Time frame: 3 min after intervention
Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
1 secondary outcome
reversed hepatic venous flow
Time frame: 3 min after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing low PEEP conventional ventilation, moderate PEEP conventional ventilation and low PEEP protective ventilation in people with Valvular Heart Disease, run by Konkuk University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop Kim, MD, PhD (+82222926942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forward hepatic venous flow (time frame: 3 min after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.