NCT02457572

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

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

April 22, 2015

Last Update Submit

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.

Procedure: Valsalva maneuverOther: Fluid loading

Interventions

Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.

Also known as: Lung recruitment maneuver
Valsalva maneuver

We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid

Also known as: Balanced crystalloid infusion
Valsalva maneuver

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

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.

MeSH Terms

Interventions

Valsalva Maneuver

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

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

Locations