Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Nouira, University of Monastir
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir
ClinicalTrials.gov Identifier:
NCT02481908
First received: May 7, 2015
Last updated: June 22, 2015
Last verified: June 2015
  Purpose
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 Intervention
Obstructive Chronic Bronchitis With Acute Exacerbation
Device: STI measurements at baseline and under Valsalva maneuver

Study Type: Observational [Patient Registry]
Study Design: 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

Further study details as provided by Nouira, University of Monastir:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 166
Study Start Date: September 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: STI measurements at baseline and under Valsalva maneuver
    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).
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 7, 2015
Last Updated: June 22, 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

ClinicalTrials.gov processed this record on May 25, 2017