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Clinical Trials/NCT04947358
NCT04947358
Unknown
Not Applicable

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

S Form Pharma1 site in 1 country180 target enrollmentFebruary 22, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Longitudinal Observational Study With 6 Months Follow-up
Sponsor
S Form Pharma
Enrollment
180
Locations
1
Primary Endpoint
Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2019
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
S Form Pharma
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital

Time Frame: 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 Outcomes

  • Proportion and causes of re-hospitalization and deaths within 6 months of discharge from hospital(6 months)

Study Sites (1)

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