Use of PARniv for Early Diagnosis of LVF in AECOPD

COPD Exacerbation Clinical Trial

Official title:

Study of Pressure Support Under Non-invasive Ventilation in the Early Diagnosis of Left Ventricular Failure During Acute Exaverbation of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05189119
• Other study ID #: pressure support /LVF/ AECOPD
• Status: Completed
• Start date: January 3, 2022
• Est. completion date: May 3, 2022

Study information

• Verified date: May 2022
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 the application of pressure support under NIV could be useful in this issue.

Description:

Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very often underestimated. Until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the Swan-ganz catheter has been stated as reference. Other noninvasive diagnostic methods have been studied, such as systolic time intervals and Valsalva maneuver, but their application still difficult in patients with COPD exacerbation, especially in emergency department (ED) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the PAR using non invasive ventilation (NIV) for the early identification of left ventricular failure (LVF) in patients presenting to the ED with acute COPD exacerbation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 3, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with a history of COPD

• consulted the emergency department for AECOPD defined by a respiratory rate >25c/min, SaO2 <90%, pH <7.35 and PaCO2 >6kPa were included.

Exclusion Criteria:

• hemodynamic instability requiring the use of vasoactive drugs

• patients with contraindications to NIV (Glasgow score <12, swallowing disorder or severe bronchial obstruction, vomiting, and those with upper airway obstruction or ongoing upper gastrointestinal bleeding and altered bronchial clearance)

• non cooperative patients

• who refused to give consent.

Related Conditions & MeSH terms

• Acute Heart Failure
• COPD Exacerbation
• Heart Failure

Intervention

Diagnostic Test:
• non invasive ventilation
invasive mechanical ventilation session in the BIPAP Mode with a pressure support (PS) level of 5cmH2O, a positive end expiratory pressure (PEEP) level of 5 cmH2O and an inspiratory fraction of oxygen (FiO2) allowing a pulse saturation (SpO2) of at least 92% for a one minute and followed by an increase of the PS level to 30cmH2O.The plethysmographic PAR (PAR) was calculated based on the following formula: PARpleth= PP30 / PP5

Locations

Country	Name	City	State
Tunisia	University hospital of Monastir	Monastir

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