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

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ClinicalTrials.gov Identifier: NCT04174794
Recruitment Status : Terminated (COVID-19 Pandemic)
First Posted : November 22, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Leidi, University Hospital, Geneva

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.

Condition or disease Intervention/treatment
Acute Heart Failure Device: Lung ultrasound

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)
Actual Study Start Date : October 8, 2019
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Lung ultrasound
    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.
    Other Name: Philips Sparq® ultrasound system; Philips AG Health Systems


Primary Outcome Measures :
  1. Inter-observer disagreement at admission lung ultrasound [ Time Frame: Day 0 ]
    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).

  2. Inter-observer disagreement at follow-up lung ultrasound [ Time Frame: Day 4 to 6 ]
    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).


Secondary Outcome Measures :
  1. Time consumption for images acquisition and interpretation at admission lung ultrasound [ Time Frame: Day 0 ]
    The time spent for images acquisition and interpretation is measured in both 28-point and 8-point protocols.

  2. Time consumption for images acquisition and interpretation at follow-up lung ultrasound [ Time Frame: Day 4 to 6 ]
    The time spent for images acquisition and interpretation is measured in both 28-point and 8-point protocols.

  3. Change in interstitial syndrome severity scale and amount of B-lines at follow-up ultrasound from baseline [ Time Frame: Day 0, Day 4 to 6 ]
    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.

  4. Post-discharge readmission and mortality at 30 days [ Time Frame: Day 30 post-discharge ]
    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

  5. Post-discharge readmission and mortality at 60 days [ Time Frame: Day 60 post-discharge ]
    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

  6. Post-discharge readmission and mortality at 90 days [ Time Frame: Day 90 post-discharge ]
    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

  7. Post-discharge readmission and mortality at 180 days [ Time Frame: Day 180 post-discharge ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174794


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
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Responsible Party: Antonio Leidi, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04174794    
Other Study ID Numbers: 2019-01596
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Leidi, University Hospital, Geneva:
Acute heart failure
Lung ultrasound
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases