Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)

Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)

In Switzerland 15% of discharged patients are readmitted within 30 days. Acute heart failure is the leading cause of hospital admission and one of the most frequent reasons for re-admission, mainly because of congestion-driven symptoms. Residual congestion is noted in 10%-15% of patients at discharge and is associated with an increased risk of re-admission and mortality. Lung ultrasound outperforms both chest X-ray and physical examination in detection of lung congestion. Several semiquantitative scanning protocols exist for quantifying congestion. The aim of this study is to compare for the first time two widely used lung ultrasound protocols, one exhaustive (28-points) and one simplified (8-points), in real-time settings. The focus is placed on reproducibility (expert-beginner interobserver concordance), feasibility (time consumption for images acquisition and interpretation) and performance (detection of B-lines clearing) of both scores. Semi-quantitative method is expected to have better feasibility with similar reproducibility and performance.

Study Overview

• Status: Terminated
• Conditions: Acute Heart Failure
• Intervention / Treatment: Device: Lung ultrasound

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of 90 patients admitted to from the emergency room to a general internal medicine ward of a tertiary care center with the diagnosis of acute heart failure

Description

Inclusion Criteria:

• Diagnosis of acute heart failure on admission chart (primary or secondary diagnosis)
• Admission from the emergency room to a general internal medicine ward
• Presentation of acute heart failure according to European Society of Cardiology :
• Presence of ≥1 symptom or sign based on admission chart review and
• Raised value of N terminal-pro-brain natriuretic peptide (>300 ng/l)

Exclusion Criteria:

• Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion, previous lung surgery
• Inability or unwillingness to give consent
• Presence of oligo-anuric end stage renal disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-observer disagreement at admission lung ultrasound	The primary endpoint is the amount of disagreement between beginner and expert echographers at admission lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels interstitial syndrome (IS) severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).	Day 0
Inter-observer disagreement at follow-up lung ultrasound	The amount of disagreement between beginner and expert echographers is measured at follow-up lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels IS severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).	Day 4 to 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time consumption for images acquisition and interpretation at admission lung ultrasound	The time spent for images acquisition and interpretation is measured in both 28-point and 8-point protocols.	Day 0
Time consumption for images acquisition and interpretation at follow-up lung ultrasound	The time spent for images acquisition and interpretation is measured in both 28-point and 8-point protocols.	Day 4 to 6
Change in interstitial syndrome severity scale and amount of B-lines at follow-up ultrasound from baseline	The clearing of B-lines following decongestive therapy is analysed and correlated to a clinical congestion score evolution, the loss of weight, N terminal-pro-brain natriuretic peptide value decline.	Day 0, Day 4 to 6
Post-discharge readmission and mortality at 30 days	The analysis of correlation between admission, follow-up lung ultrasound IS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 30 days post-discharge	Day 30 post-discharge
Post-discharge readmission and mortality at 60 days	The analysis of correlation between admission, follow-up lung ultrasound IS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 60 days post-discharge	Day 60 post-discharge
Post-discharge readmission and mortality at 90 days	The analysis of correlation between admission, follow-up LUS ISSS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 90 days post-discharge	Day 90 post-discharge
Post-discharge readmission and mortality at 180 days	The analysis of correlation between admission, follow-up lung ultrasound IS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 180 days post-discharge	Day 180 post-discharge

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Lung ultrasound; Acute heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019-01596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No