Use of PARniv for Early Diagnosis of LVF in AECOPD

NCT ID: NCT05189119

Last Updated: 2022-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-05-03

Brief Summary

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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.

Detailed Description

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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

Conditions

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Acute Heart Failure COPD Exacerbation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LVFgroup

patients with AECOPD and left ventricular failure

non invasive ventilation

Intervention Type 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

non LVF group

patients with AECOPD and whithout left ventricular failure

non invasive ventilation

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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NIV

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Pr. Semir Nouira

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University hospital of Monastir

Monastir, , Tunisia

Site Status

Countries

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Tunisia

References

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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.

Reference Type DERIVED
PMID: 36829108 (View on PubMed)

Other Identifiers

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pressure support /LVF/ AECOPD

Identifier Type: -

Identifier Source: org_study_id

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