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Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure in Chronic Obstructive Pulmonary Disease Exacerbation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01619540
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir

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.


Condition or disease Intervention/treatment Phase
Acute Heart Failure COPD Exacerbation Other: Valsalva maneuver Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Study of the Valsalva Manœuvre in the Diagnosis of Left Ventricular Failure During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Start Date : May 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
acute heart failure
control arm
Other: Valsalva maneuver
Experimental: COPD exacerbation
COPD exacerbation
Other: Valsalva maneuver



Primary Outcome Measures :
  1. left ventricular dysfunction [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619540


Locations
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Tunisia
University Hospital of Monastir
Monastir, Monstir, Tunisia, 5000
Fattouma Bourguiba University hospital
Monastir, Tunisia, 5000
University hospital of Moastir
Monastir, Tunisia, 5000
University hospital of Monastir
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
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Principal Investigator: Nouira Semir, Professor Monastir University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nouira, Study of the Valsalva Manœuvre in Diagnoses of Left Ventricular Failure During Acute Exacerbation of Chronic Obstructive Pulmonary Desease, University of Monastir
ClinicalTrials.gov Identifier: NCT01619540    
Other Study ID Numbers: Valsalva
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013
Keywords provided by Nouira, University of Monastir:
COPD
Left Ventricular Failure
Valsalva Manoeuver
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases