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Use of PARniv for Early Diagnosis of LVF in AECOPD

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT05189119
Collaborator
(none)
80
Enrollment
1
Location
3.9
Actual Duration (Months)
20.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: non invasive ventilation

Detailed 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

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 3, 2022
Actual Primary Completion Date :
May 3, 2022
Actual Study Completion Date :
May 3, 2022

Arms and Interventions

Arm Intervention/Treatment
LVFgroup

patients with AECOPD and left ventricular failure

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
Other Names:
  • NIV

    		•
    non LVF group

    patients with AECOPD and whithout left ventricular failure

    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
    Other Names:
  • NIV

    		•

    Outcome Measures

    Primary Outcome Measures

    1. left ventricular dysfunction [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital of Monastir Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05189119
    Other Study ID Numbers:
    • pressure support /LVF/ AECOPD
    First Posted:
    Jan 12, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, professor, University of Monastir
    COPD
    Left Ventricular Failure
    Pressure Support under NIV
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of May 27, 2022