Acute Heart FailureNCT05189119
Use of PARniv for Early Diagnosis of LVF in AECOPD
An observational study of Acute Heart Failure and COPD Exacerbation, run by University of Monastir at 1 site in Tunisia.
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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Heart Failure, COPD Exacerbation
- What is being tested?
- non invasive ventilation
- How many people
- 80 participants
- Where
- 1 siteTunisia
- Study dates
- 3 Jan 2022to 3 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients presenting to the ED with an acute COPD exacerbation
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Acute Heart Failure, COPD Exacerbation
- Being tested
- non invasive ventilation
- Keywords
- COPD, Left Ventricular Failure, Pressure Support under NIV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive ventilationDiagnostic test
Also called NIV
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
| Study group | Role | What they receive |
|---|---|---|
| LVFgroup | patients with AECOPD and left ventricular failure Receives: Diagnostic Test: non invasive ventilation | |
| non LVF group | patients with AECOPD and whithout left ventricular failure Receives: Diagnostic Test: non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular dysfunction
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start3 Jan 2022
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189119
- Sponsor's protocol ID
- pressure support /LVF/ AECOPD
- Status last verified
- May 2022
- First submitted
- 27 Dec 2021
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36829108
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05189119
- Acronym / sponsor ID
- pressure support /LVF/ AECOPD
- Conditions
- Acute Heart Failure, COPD Exacerbation
- Keywords
- COPD, Left Ventricular Failure, Pressure Support under NIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVFgroup | – | Diagnostic Test: non invasive ventilationpatients with AECOPD and left ventricular failure |
| non LVF group | – | Diagnostic Test: non invasive ventilationpatients with AECOPD and whithout left ventricular failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients presenting to the ED with an acute COPD exacerbation
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive ventilationAlso: NIVinvasive 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 | Diagnostic test | LVFgroup, non LVF group |
Primary outcome
left ventricular dysfunction
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 36829108Bel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and COPD Exacerbation, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular dysfunction (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05189119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.