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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir
ClinicalTrials.gov Identifier:
NCT01619540
First received: June 12, 2012
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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 Intervention
Acute Heart Failure
COPD Exacerbation
Other: Valsalva maneuver

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Monastir:

Primary Outcome Measures:
  • left ventricular dysfunction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: May 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
acute heart failure
control arm
Other: Valsalva maneuver
Experimental: COPD exacerbation
COPD exacerbation
Other: Valsalva maneuver

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619540

Locations
Tunisia
University Hospital of Monastir
Monastir, Monstir, Tunisia, 5000
University hospital of Moastir
Monastir, Tunisia, 5000
University hospital of Monastir
Monastir, Tunisia, 5000
Fattouma Bourguiba University hospital
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: Nouira Semir, Professor Monastir University
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: Valsalva
Study First Received: June 12, 2012
Last Updated: September 23, 2013
Health Authority: Tunisia: Ministry of Public Health

Keywords provided by University of Monastir:
COPD
Left Ventricular Failure
Valsalva Manoeuver

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014