NCT02481908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

May 7, 2015

Last Update Submit

September 10, 2020

Conditions

Obstructive Chronic Bronchitis With Acute Exacerbation

Keywords

AECOPDleft ventricular dysfunctionvalsalva maneuversystolic time intervals

Outcome Measures

Primary Outcomes (1)

  • diagnosis of left ventricular dysfunction

    Systolic time intervals measured at baseline and under Valsalva maneuver

    during the first day admission in emergency department

Interventions

STI measurements at baseline and under Valsalva maneuverDEVICE

STI measurements at baseline and under Valsalva maneuver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • SEMIR NOUIRA, Pr

    Fattouma Bourguiba University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2015

First Posted

June 25, 2015

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations

TU(1)