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STI Combined to Valsalva Maneuver for the Diagnosis of Left Ventricular Dysfunction in COPD Exacerbations (STICOPD)

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ClinicalTrials.gov Identifier: NCT02481908
Recruitment Status : Unknown
Verified June 2015 by Nouira, University of Monastir.
Recruitment status was:  Recruiting
First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this investigation was to assess the value of Systolic Time Intervals (STIs) as a method of detecting Left Ventricular Dysfunction (LVD) in patients admitted to the ED for Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) and whether STIs measured under Valsalva manoeuver (VM) could improve the distinction between patients with LVD and those without LVD.

Condition or disease Intervention/treatment
Obstructive Chronic Bronchitis With Acute Exacerbation Device: STI measurements at baseline and under Valsalva maneuver

Detailed Description:
We included patients admitted to the ED for AECOPD. Measurement of STIs included electromechanical activation time (EMAT), left ventricular ejection time and EMAT/LVET ration. These were performed at baseline and during the first strain phase of the VM using a computerized phonoelectrocardiographic method. The diagnosis of LVD was determined on the basis of clinical examination, echocardiography and brain natriuretic peptide. The values of STIs were compared between patients with and without LVD ; their diagnostic performance was assessed using the area under receiver operating characteristic curve (AUC of ROC).

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: a New and Non Invasive Method to Calculate STI ( Systolic Time Intervals) Combined to Valsalva Maneuver in Patient With Acute Exacerbation of COPD
Study Start Date : September 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015
Groups and Cohorts

Intervention Details:
    Device: STI measurements at baseline and under Valsalva maneuver
    STI measurements at baseline and under Valsalva maneuver

Outcome Measures

Primary Outcome Measures :
  1. diagnosis of left ventricular dysfunction [ Time Frame: during the first day admission in emergency department ]
    Systolic time intervals measured at baseline and under Valsalva maneuver


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
It is a prospective study of patients visiting the emergency department of the hospital Fattouma Bourguiba Monastir with decompensated chronic obstructive pulmonary disease COPD
Criteria

Inclusion Criteria:

  • SPO2<90%,
  • RR>25c/min,
  • PaCO2 > 6kPa et pH< 7.35.

Exclusion Criteria:

  • Neurological distress and | or unstable hemodynamics
  • Confusion, agitation
  • pneumothorax
  • No cooperation from the patient
  • Refusal of consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481908


Contacts
Contact: SEMIR NOUIRA, Pr 52432582 semir.nouira@rns.tn

Locations
Tunisia
CHU Fattouma Bourguiba Recruiting
Monastir, Tunisia, 5000
Contact: semir nouira, Pr    52432582      
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: SEMIR NOUIRA, Pr Fattouma Bourguiba University Hospital
More Information

Responsible Party: Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02481908     History of Changes
Other Study ID Numbers: STI in COPD
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Nouira, University of Monastir:
AECOPD
left ventricular dysfunction
valsalva maneuver
systolic time intervals

Additional relevant MeSH terms:
Bronchitis
Ventricular Dysfunction
Bronchitis, Chronic
Ventricular Dysfunction, Left
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Heart Diseases
Cardiovascular Diseases
Pulmonary Disease, Chronic Obstructive