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

NCT ID: NCT04174794

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2020-03-16

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Philips Sparq® ultrasound system; Philips AG Health Systems

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Antonio Leidi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Geneva University Hospitals

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

2019-01596

Identifier Type: -

Identifier Source: org_study_id