Cardiac Surgical ProceduresNCT02457572
Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition
An observational study of Cardiac Surgical Procedures and Thoracic Surgical Procedures, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid responsiveness. However, its usefulness in open-chest conditions has been equivocal. The investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid responsiveness after sternotomy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiac Surgical Procedures, Thoracic Surgical Procedures, Sternotomy
- What is being tested?
- Valsalva maneuver and Fluid loading
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to May 2015
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective off-pump coroanry arterial bypass grafting
Who may be able to join
- Adult patients undergoing elective off-pump coronary arterial bypass grafting
Who cannot join
- Preoperative LV EF <= 35%
- Moderate or severe valvular heart disease
- Cardiac arrhythmia
- Intracardiac shunt
- Severe renal or liver disease
- Moderate to severe pulmonary hypertension (mean PAP > 35 mmHg)
- Patients with bullous lung disease or combined pneumothorax
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition in the Patients Undergoing Off-pump Coronary Arterial Bypass Grafting
Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid responsiveness. However, its usefulness in open-chest conditions has been equivocal. The investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid responsiveness after sternotomy.
- Being tested
- Valsalva maneuver, Fluid loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva maneuverProcedure or surgery
Also called Lung recruitment maneuver
Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.
Fluid loadingOther
Also called Balanced crystalloid infusion
We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid
| Study group | Role | What they receive |
|---|---|---|
| Valsalva maneuver | This is an observational study and as a diagnostic intervention, subjects in the study would receive valsalva maneuver. Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration. The investigators perform this procedure to every patients and do not assign this intervention to the subjects of the study. Receives: Procedure: Valsalva maneuver; Other: Fluid loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse pressure variation during Valsalva maneuver
Measured: during Valsalva maneuver
Secondary outcomes (1)
Pulse pressure variation after sternotomy
Measured: 5 min after sternotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457572
- Sponsor's protocol ID
- SMC 2014-07-005
- Status last verified
- Sep 2015
- First submitted
- 22 Apr 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
Publications
Min JJ, Kim TK, Lee JH, Park J, Cho HS, Kim WS, Lee YT. Evaluation of augmented pulse pressure variation using the Valsalva manoeuvre as a predictor of fluid responsiveness under open-chest conditions: A prospective observational study. Eur J Anaesthesiol. 2017 May;34(5):254-261. doi: 10.1097/EJA.0000000000000613.
PubMed 28207430
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition in the Patients Undergoing Off-pump Coronary Arterial Bypass Grafting
- ClinicalTrials.gov ID
- NCT02457572
- Acronym / sponsor ID
- SMC 2014-07-005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 May 2015 (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.
Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid responsiveness. However, its usefulness in open-chest conditions has been equivocal. The investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid responsiveness after sternotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valsalva maneuver | – | Procedure: Valsalva maneuver, Other: Fluid loadingThis is an observational study and as a diagnostic intervention, subjects in the study would receive valsalva maneuver. Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration. The investigators perform this procedure to every patients and do not assign this intervention to the subjects of the study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective off-pump coroanry arterial bypass grafting
Key inclusion criteria (1 listed)
- Adult patients undergoing elective off-pump coronary arterial bypass grafting
Key exclusion criteria (7 listed)
- Preoperative LV EF <= 35%
- Moderate or severe valvular heart disease
- Cardiac arrhythmia
- Intracardiac shunt
- Severe renal or liver disease
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 |
|---|---|---|
| Valsalva maneuverAlso: Lung recruitment maneuverValsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration. | Procedure or surgery | Valsalva maneuver |
| Fluid loadingAlso: Balanced crystalloid infusionWe record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid | Other | Valsalva maneuver |
Primary outcome
Pulse pressure variation during Valsalva maneuver
Time frame: during Valsalva maneuver
1 secondary outcome
Pulse pressure variation after sternotomy
Time frame: 5 min after sternotomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Derived from this study: PubMed 28207430Min JJ, Kim TK, Lee JH, Park J, Cho HS, Kim WS, Lee YT. Evaluation of augmented pulse pressure variation using the Valsalva manoeuvre as a predictor of fluid responsiveness under open-chest conditions: A prospective observational study. Eur J Anaesthesiol. 2017 May;34(5):254-261. doi: 10.1097/EJA.0000000000000613.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Procedures and Thoracic Surgical Procedures, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse pressure variation during Valsalva maneuver (time frame: during Valsalva maneuver). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02457572, which also lists 1 linked publication.
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 14 Sep 2015.