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

Obstructive Chronic Bronchitis With Acute Exacerbation Clinical Trial

— STICOPD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481908
• Other study ID #: STI in COPD
• Status: Completed
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2020
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 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.

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Obstructive Chronic Bronchitis With Acute Exacerbation
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• STI measurements at baseline and under Valsalva maneuver
STI measurements at baseline and under Valsalva maneuver

Locations

Country	Name	City	State
Tunisia	CHU Fattouma Bourguiba	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of left ventricular dysfunction	Systolic time intervals measured at baseline and under Valsalva maneuver	during the first day admission in emergency department