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

• Sponsor: University of Monastir (Other)
• Overall Status: Completed
• CT.gov ID: NCT02481908
• Collaborator: (none)
• Enrollment: 189
• Location: 1
• Actual Duration (Months): 20
• Patients Per Site Per Month: 9.4

Study Details

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 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.

Condition or Disease	Intervention/Treatment	Phase
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 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).

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 189 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Outcome Measures

Primary Outcome Measures

1. diagnosis of left ventricular dysfunction [during the first day admission in emergency department]

   Systolic time intervals measured at baseline and under Valsalva maneuver

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Fattouma Bourguiba	Monastir		Tunisia	5000

Sponsors and Collaborators

• University of Monastir

Investigators

• Principal Investigator: SEMIR NOUIRA, Pr, Fattouma Bourguiba University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
• ClinicalTrials.gov Identifier: NCT02481908
• Other Study ID Numbers: STI in COPD
• First Posted: Jun 25, 2015
• Last Update Posted: Sep 14, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Pr. Semir Nouira, Professor, University of Monastir: AECOPD; left ventricular dysfunction; valsalva maneuver; systolic time intervals
• Additional relevant MeSH terms: Bronchitis; Bronchitis, Chronic; Ventricular Dysfunction; Ventricular Dysfunction, Left

Study Results

No Results Posted as of Sep 14, 2020