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Completed

NCT Number: NCT02481908

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

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 emergency department for cute 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.

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Key information

Conditions

Obstructive Chronic Bronchitis With Acute Exacerbation Cardiovascular Diseases Heart Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Fattouma Bourguiba

Monastir, 5000, Tunisia

About this study

We included patients admitted to the ED for AECOPD. Measurement of STIs included electromechanical activation time (EMAT), left ventricular ejection time and EMAT/LVET ratio. These were performed at baseline and during the first strain phase of the VM using a computerized phono and electrocardiographic 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Oxygen Saturation (SPO2) <90%,
  • Respiratory Rate >25c/min,
  • PaCO2 > 6 kPa et pH< 7.35.

Exclusion criteria

  • Neurological distress and hemodynamic instability
  • Confusion, agitation
  • pneumothorax
  • Non cooperative patients
  • Refusal of consent

Treatment and study plan

STI measurements at baseline and under Valsalva maneuver

Device

STI measurements at baseline and under Valsalva maneuver

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

a New and Non Invasive Method to Calculate STI ( Systolic Time Intervals) Combined to Valsalva Maneuver in Patient With Acute Exacerbation of COPD

Acronym: STICOPD

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2015
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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