NCT03349593

Brief Summary

Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population. The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Typical duration 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

First Submitted

Initial submission to the registry

November 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

January 5, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

November 17, 2017

Last Update Submit

December 15, 2021

Conditions

HypovolemiaHeart FailureDiastolic DysfunctionSystolic DysfunctionVenous; Return (Anomaly)

Keywords

Heart failure, diastolic dysfunction, venous returnLeft ventricular filling pressures

Outcome Measures

Primary Outcomes (2)

  • Hypovolemia

    Screening of preoperative level of venous return

    One hour before surgery

  • Heart failure

    Screening of incidence of preoperative systolic and diastolic function

    One hour before surgery

Interventions

EchocardiographyDIAGNOSTIC_TEST

Preoperative transthoracic echocardiography

Eligibility Criteria

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

Electively scheduled individuals for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

You may qualify if:

  • body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

You may not qualify if:

  • Not signed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunderby hospital

Luleå, 97180, Sweden

Location

Related Publications (1)

  • Stenberg Y, Rhodin Y, Lindberg A, Aroch R, Hultin M, Wallden J, Myrberg T. Pre-operative point-of-care assessment of left ventricular diastolic dysfunction, an observational study. BMC Anesthesiol. 2022 Apr 5;22(1):96. doi: 10.1186/s12871-022-01642-4.

    PMID: 35382761DERIVED

MeSH Terms

Conditions

HypovolemiaHeart FailureCongenital Abnormalities

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Tomi P Myrberg, MD PhD

    Umeå University, Norrbotten county concil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 21, 2017

Study Start

December 1, 2017

Primary Completion

November 30, 2018

Study Completion

December 30, 2019

Last Updated

January 5, 2022

Record last verified: 2021-12

Locations

SE(1)