Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial

NCT04174794 | Terminated

• 1 other identifier: 2019-01596
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Heart Failure

Keywords

Acute heart failure; Lung ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Time consumption for images acquisition and interpretation at admission lung ultrasound

  Day 0

• Time consumption for images acquisition and interpretation at follow-up lung ultrasound

  Day 4 to 6

• Change in interstitial syndrome severity scale and amount of B-lines at follow-up ultrasound from baseline

  Day 0, Day 4 to 6

• Post-discharge readmission and mortality at 30 days

  Day 30 post-discharge

• Post-discharge readmission and mortality at 60 days

  Day 60 post-discharge

Interventions

Lung ultrasound DEVICE

The two different lung ultrasound protocols are performed initially within 48 hours of internal medicine ward admission by a pair of expert-beginner echographers. In case of admission during non-working days, the first scan can be done within 72 hours from admission. Follow-up scans are repeated 4 to 6 days later or on the day of discharge if it occurs before de fourth day. Experts and beginners execute the lund ultrasound protocols in sequence, reciprocally blinded, without accessing to clinical data files.

Also known as: Philips Sparq® ultrasound system; Philips AG Health Systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

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 19, 2019
• First Posted: November 22, 2019
• Study Start: October 8, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)