Focused Cardiac Ultrasound in Surgery

NCT03501927 | Terminated DMC

• 1 other identifier: PreOPFOCUS
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

Brief Summary

Mortality and morbidity remain high after non-cardiac surgery. Known risk factors include age, high ASA grade and emergency surgery. Point-of-care focused cardiac ultrasound may elucidate pathology and potential hemodynamic compromise unknown to handling physicians. This study aims to investigate the effects of focused cardiac ultrasound in high-risk patients undergoing non-cardiac surgery with respect to clinical endpoints.

Conditions

Cardiopulmonary Disease; Surgery; Morality; Complication

Keywords

Ultrasound; FOCUS; Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients admitted to hospital ≥ 10 days or dead within 30 days

  30 days after surgery

Secondary Outcomes (35)

• Length of stay

  Up to 180 days after surgery

• Re-admissions to hospital

  Up to 90 days after surgery

• Length of stay

  Up to 90 days after surgery

• Death ≤ 30 days & ≤ 90 days

  Up to 90 days after surgery

• Intensive care treatment

  Up to 90 days after surgery

Study Arms (2)

FOCUS (focused cardiac ultrasound)

ACTIVE COMPARATOR

Patients allocated to FOCUS will receive a preoperative FOCUS examination in conjunction with a standard anesthetic preoperative evaluation.

Diagnostic Test: FOCUS (focused cardiac ultrasound)

Control

NO INTERVENTION

Patients allocated til control arm will receive a standard anesthetic preoperative evaluation according to hospitals' standards.

Interventions

FOCUS (focused cardiac ultrasound) DIAGNOSTIC_TEST

A ultrasound of the heart and pleura will be performed. This provide information on * Left ventricular systolic function * Left ventricular diastolic function * Right ventricular systolic function * Right ventricular pressure overload * Biventricular sizes * Pathology of the mitral- and aortic valves * Pericardial fluid * Gross fluid status * Pleural effusion

FOCUS (focused cardiac ultrasound)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients scheduled for emergency (\< 6 hours) or urgent surgery (\< 24 hours)15
• General or neuro-axial anaesthesia planned at the first anesthetic visit
• ASA classification 3 or 4.
• Age ≥ 65 years

You may not qualify if:

• Previous surgery performed during current hospital admission (including transfers from other hospitals than Randers Regional Hospital/Hospital of Southern Jutland)
• Low risk surgery or expected surgery time \< 30 minutes or endoscopies.
• Lack of consent from patient or proxy (in case of patient mental incapacity)
• Previous participation in the study. Pre-operative FOCUS not possible for logistical reasons or due to requirement for immediate surgery
• Drop-out Criteria:
• Patients converted from a primary anaesthetic plan of general/neuro-axial anaesthesia to regional anaesthesia will not drop-out. -

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Randers Regional Hospital: collaborator
• Aabenraa Hospital: collaborator

Study Sites (1)

Department of Anaesthesiology

Randers, Denmark

Location

Related Publications (27)

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  PMID: 31908251 DERIVED

MeSH Terms

Conditions

Pulmonary Heart Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jan Pallesen, MD

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

• Rajesh Bhavsar, MD

  Aabenraa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Preoperative point-of-care focused cardiopulmonary ultrasound (FOCUS) Patients are to be randomised in a 1:1 ratio to either 1) FOCUS prior to anaesthesia or 2) no FOCUS performed (standard treatment).

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: April 18, 2018
• Study Start: May 7, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Protocol within 6 months of study commencement Study results within 6 months of study termination
• Access Criteria: Public

Locations

DK (1)