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

Primary Purpose

Acute Heart Failure, COPD Exacerbation

Status

Completed

Phase

Not Applicable

Locations

Tunisia

Study Type

Interventional

Intervention

Valsalva maneuver

About this trial

This is an interventional diagnostic trial for Acute Heart Failure focused on measuring COPD, Left Ventricular Failure, Valsalva Manoeuver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University Hospital of Monastir
Fattouma Bourguiba University hospital
University hospital of Moastir
University hospital of Monastir

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

acute heart failure

COPD exacerbation

Arm Description

control arm

COPD exacerbation

Outcomes

Primary Outcome Measures

left ventricular dysfunction

Secondary Outcome Measures

Full Information

NCT ID

NCT01619540

First Posted

June 12, 2012

Last Updated

September 23, 2013

Sponsor

University of Monastir

1. Study Identification

Unique Protocol Identification Number

NCT01619540

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Monastir

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure, COPD Exacerbation

Keywords

COPD, Left Ventricular Failure, Valsalva Manoeuver

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

acute heart failure

Arm Type

Other

Arm Description

control arm

Arm Title

COPD exacerbation

Arm Type

Experimental

Arm Description

COPD exacerbation

Intervention Type

Other

Intervention Name(s)

Valsalva maneuver

Primary Outcome Measure Information:

Title

left ventricular dysfunction

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nouira Semir, Professor

Organizational Affiliation

Monastir University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Monastir

City

Monastir

State/Province

Monstir

ZIP/Postal Code

5000

Country

Tunisia

Facility Name

Fattouma Bourguiba University hospital

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

Facility Name

University hospital of Moastir

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

Facility Name

University hospital of Monastir

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

12. IPD Sharing Statement

Citations:

PubMed Identifier

26647450

Citation

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.

Results Reference

derived

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

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