Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition
1 other identifier
observational
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Oct 2014
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedSeptember 14, 2015
September 1, 2015
7 months
April 22, 2015
September 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pulse pressure variation during Valsalva maneuver
during Valsalva maneuver
Secondary Outcomes (1)
Pulse pressure variation after sternotomy
5 min after sternotomy
Study Arms (1)
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.
Interventions
Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.
We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid
Eligibility Criteria
Adult patients undergoing elective off-pump coroanry arterial bypass grafting
You may qualify if:
- \- Adult patients undergoing elective off-pump coronary arterial bypass grafting
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
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.
PMID: 28207430DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 22, 2015
First Posted
May 29, 2015
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
September 14, 2015
Record last verified: 2015-09