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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Eric Halioua, CEO; Phone Number: +32474057866; Email: halioua_eric@yahoo.fr

Study Locations

• Tunisia
  • Monastir, Tunisia
    • Recruiting
    • ER, Fattouma Bourguiba Hospital
    • Contact: Semir Nouira; Phone Number: +21673106085; Email: semir.nouira@rns.tn
    • Principal Investigator: Riadh Boukef
    • Principal Investigator: Houda Ben Soltane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for unexpected respiratory difficulty

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital	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	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: S Form Pharma

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: AD201801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No