NCT01619540

Brief Summary

Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis . The investigators expect that Valsalva Maneuver (VM) could be useful in this issue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

June 12, 2012

Last Update Submit

September 23, 2013

Conditions

Acute Heart FailureCOPD Exacerbation

Keywords

COPDLeft Ventricular FailureValsalva Manoeuver

Outcome Measures

Primary Outcomes (1)

  • left ventricular dysfunction

    24 hours

Study Arms (2)

acute heart failure

OTHER

control arm

Other: Valsalva maneuver

COPD exacerbation

EXPERIMENTAL

COPD exacerbation

Other: Valsalva maneuver

Interventions

Valsalva maneuverOTHER
COPD exacerbationacute heart failure

Eligibility Criteria

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

You may qualify if:

  • We included in this group, patients with a history (previous history) of COPD who consulted the emergency room for an exacerbation of COPD defined by a respiratory rate\> 25c/min and a pH \<7.35 and a PaCO2 \>6 KPa.
  • This group is also divided into two groups according to clinical expert assessment and the BNP value: Group1 : BNP\> 400pg/ml, Group2 : BNP \<400PG / ml

You may not qualify if:

  • We excluded from this study patients with Prominent cardiac arrest
  • Rhythm disorders including severe tachycardia arrhythmia
  • Auricular fibrillation
  • Hemodynamic instability requiring the use of vasoactive drugs and a contre indications of non invasive ventilation such us consciousness disorders with a Glasgow score \<12/15,a swallowing disorder
  • A significant bronchial obstruction ,the upper airway obstruction , in upper gastrointestinal bleeding in progress, an extreme obesity and Cirrhosis or cancer.
  • We are also excluded patients who did not cooperate and those who refused the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fattouma Bourguiba University hospital

Monastir, Monastir Governorate, 5000, Tunisia

Location

University hospital of Moastir

Monastir, Monastir Governorate, 5000, Tunisia

Location

University hospital of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

Location

University Hospital of Monastir

Monastir, Monstir, 5000, Tunisia

Location

Related Publications (1)

  • Boubaker H, Grissa MH, Debbabi H, Beltaief K, Dridi Z, Najjar MF, Bouida W, Boukef R, Marghli S, Nouira S. Value of Plethysmographic Pulse Amplitude Ratio With Valsalva Maneuver in Identifying Left Ventricular Dysfunction During COPD Exacerbation. Respir Care. 2016 Apr;61(4):439-46. doi: 10.4187/respcare.04091. Epub 2015 Dec 8.

    PMID: 26647450DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart Failure

Interventions

Valsalva Maneuver

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

Study Officials

  • Nouira Semir, Professor

    Monastir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study of the Valsalva Manœuvre in Diagnoses of Left Ventricular Failure During Acute Exacerbation of Chronic Obstructive Pulmonary Desease

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

May 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

TU(4)