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

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619540
• Other study ID #: Valsalva
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: September 23, 2013
• Start date: May 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Heart Failure
• COPD Exacerbation
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Valsalva maneuver

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University hospital	Monastir
Tunisia	University hospital of Moastir	Monastir
Tunisia	University hospital of Monastir	Monastir
Tunisia	University Hospital of Monastir	Monastir	Monstir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular dysfunction		24 hours	No