Use of PARniv for Early Diagnosis of LVF in AECOPD

NCT05189119 | Completed

• 1 other identifier: pressure support /LVF/ AECOPD
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Heart Failure; COPD Exacerbation

Keywords

COPD; Left Ventricular Failure; Pressure Support under NIV

Outcome Measures

Primary Outcomes (1)

• left ventricular dysfunction

  24 hours

Study Arms (2)

LVFgroup

patients with AECOPD and left ventricular failure

Diagnostic Test: non invasive ventilation

non LVF group

patients with AECOPD and whithout left ventricular failure

Diagnostic Test: non invasive ventilation

Interventions

non invasive ventilation DIAGNOSTIC_TEST

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

Also known as: NIV

LVFgroup; non LVF group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients presenting to the ED with an acute COPD exacerbation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

University hospital of Monastir

Monastir, 5000, Tunisia

Location

Related Publications (1)

• Bel Haj Ali K, Sekma A, Chamtouri I, Beltaief K, Msolli MA, Mezgar Z, Bouida W, Boukef R, Boubaker H, Grissa MH, Nouira S. Pulse amplitude ratio under noninvasive ventilation as a new method in the diagnosis of left heart failure in patients with acute exacerbation of chronic obstructive pulmonary disease. BMC Cardiovasc Disord. 2023 Feb 24;23(1):105. doi: 10.1186/s12872-023-03089-y.

  PMID: 36829108 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: January 3, 2022
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

TU (1)