NCT04202432

Brief Summary

Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

December 16, 2019

Last Update Submit

December 17, 2019

Conditions

Shock, CardiogenicShock HypovolemicHypovolemiaCardiac Failure

Keywords

Mean Systemic Filling PressurePmsPmsfHypovolemiaCardiac OutputTranspulmonary thermodilutionTransesophageal echocardiographyVolume stateCritical CareCardiosurgeryIntensive CareCarotid ultrasoundPulsed WaveInspiratory breath hold

Outcome Measures

Primary Outcomes (1)

  • Clinical validation of Pms-algorithm

    To determine a correlation between Pms calculated by a computerized algorithm by Navigator(TM) (Pms-Nav) and the gold standard for determining Pms: Pms-Insp. The latter is calculated by performing inspiratory breath holds during incremental airway pressure levels thereby simulating a decrease in preload which, by extrapolating a venous return curve, leads to the true Pms when the curve intersects the x-axis (Pms-Insp).

    Hours

Secondary Outcomes (1)

  • Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement.

    Hours

Study Arms (1)

Coronary Artery Bypass Surgery patients

Patients undergoing coronary artery bypass surgery (on-pump / off-pump) measured perioperatively and postoperatively.

Diagnostic Test: Mean systemic filling pressure

Interventions

Mean systemic filling pressureDIAGNOSTIC_TEST

Peri- and postoperative measurement of continuous cardiac output with thermodilution derived pulse contour calculated device (PiCCO). Estimation of mean systemic filling pressure using a computerized algorithm and by creating venous return curves with inspiratory hold maneuvers, thereby extrapolating the VR-curve until mean systemic filling pressure is calculated.

Also known as: Measurement of cardiac output
Coronary Artery Bypass Surgery patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing coronary artery bypass grafting with a good left and right ventricular ejection fraction, no significant valvular insufficiencies/stenoses and no significant comorbidity.

You may qualify if:

  • Good left and right ventricular ejection fraction
  • No significant valvular insufficiencies/stenoses
  • No significant comorbidity
  • Signed informed consent
  • Elective coronary artery bypass surgery
  • Postoperative mechanically ventilated admitted to the PACU

You may not qualify if:

  • Withdrawal informed consent
  • History of pneumonectomy of lobectomy
  • Mechanical support of circulation
  • COPD Gold 3 or 4
  • Complications during surgery
  • Postoperative bleeding \>50mL/15 minutes after admission to PACU - No thoracic drain in pleura
  • Postoperative pneumothorax
  • Participation in other research studies/trials
  • Elevated intra-abdominal surgery (\>12 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (1)

  • Meijs LPB, van Houte J, Conjaerts BCM, Bindels AJGH, Bouwman A, Houterman S, Bakker J. Clinical validation of a computerized algorithm to determine mean systemic filling pressure. J Clin Monit Comput. 2022 Feb;36(1):191-198. doi: 10.1007/s10877-020-00636-2. Epub 2021 Mar 31.

    PMID: 33791920DERIVED

MeSH Terms

Conditions

Shock, CardiogenicShockHypovolemiaHeart FailurePremenstrual Syndrome

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisMenstruation Disturbances

Study Officials

  • LPB Meijs, MD

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist, fellow intensive care medicine, PhD candidate Intensive Care Medicine

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 17, 2019

Study Start

June 24, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

December 18, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

No sharing

Locations

NL(1)