Clinical trial NCT04174794: Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial
Official title: Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Heart Failure
Keywords: Acute heart failure
Lung ultrasound
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Inter-observer disagreement at admission lung ultrasound
timeFrame: Day 0
measure: Inter-observer disagreement at follow-up lung ultrasound
timeFrame: Day 4 to 6
Secondary outcomes:
measure: Time consumption for images acquisition and interpretation at admission lung ultrasound
timeFrame: Day 0
measure: Time consumption for images acquisition and interpretation at follow-up lung ultrasound
timeFrame: Day 4 to 6
measure: Change in interstitial syndrome severity scale and amount of B-lines at follow-up ultrasound from baseline
timeFrame: Day 0, Day 4 to 6
measure: Post-discharge readmission and mortality at 30 days
timeFrame: Day 30 post-discharge
measure: Post-discharge readmission and mortality at 60 days
timeFrame: Day 60 post-discharge
measure: Post-discharge readmission and mortality at 90 days
timeFrame: Day 90 post-discharge
measure: Post-discharge readmission and mortality at 180 days
timeFrame: Day 180 post-discharge
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References: