Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia

• Conditions: Longitudinal Observational Study With 6 Months Follow-up

• Registration Number: NCT04947358
• Lead Sponsor: S Form Pharma

Brief Summary

The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-22
• Study First Submitted: 2019-07-19
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-23
• Last Update Submitted: 2021-06-23
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients admitted for unexpected respiratory difficulty
• Patient admitted to the emergency department
• One of the following 3 criteria have to be present at admission to the ER:
• O2 < or = 95%
• Respiratory rate RR > or = 20
• Suffocation sensation

Exclusion Criteria

• Patients <18 years old and> 85 years' old
• Pregnancy
• History of allergic asthma at early age
• Diagnosis retained of pulmonary embolism
• Patients with heart failure (HF) with left ventricular ejection fraction LVEF <40% are known beforehand or discovered at admission to ER
• known Allergy for Polyamide; Polyester; Elastane; Silicone; Silver; Synthetic material Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax Open wound on the skin, at the level of the trunk

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital	3 months	Define the proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital for patients admitted to the Emergency Department for acute dyspnea

Secondary Outcome Measures

Name	Time	Method
Proportion and causes of re-hospitalization and deaths within 6 months of discharge from hospital	6 months	Check theses parameters at 6 months, differentiating the cardiac causes from non-cardiac causes and the effect of home follow-up.

Trial Locations

Locations (1)

ER, Fattouma Bourguiba Hospital; 🇹🇳 Monastir, Tunisia