B –natriuritic peptide and troponin for diagnosis of cardiac origin weaning failure from mechanical ventilation: An observational study.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000143426
• Date of registration: 05/02/2016
• Prospective Registration: No
• Primary sponsor: Hoda Alsaid Ahmed Ezz
• Public title: B –natriuritic peptide and troponin for diagnosis of cardiac origin weaning failure from mechanical ventilation: An observational study.
• Scientific title: B –natriuritic peptide and troponin I as an alternative to echocardiography for diagnosis of cardiac origin weaning failure from mechanical ventilation : An observational study.
• Date of first enrolment: 06/04/2013
• Target sample size: 80
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000143426.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Prof Abd El Raheem M. Dowidar

• Name: Prof Abd El Raheem M. Dowidar

Key inclusion & exclusion criteria

Inclusion criteria: The patients were selected from elderly patients aged more than 60 years old, who were under mechanical ventilation for more than 48 hours and fulfilling the criteria of weaning.
Exclusion criteria: Patient below the age of 60 years old, with renal failure, end stage chronic illness, preexisting neuromuscular disease, and patients without good transthoracic echocardiography window.

Age minimum: 60 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

failure of weaning from mechanical ventilation ;
failure of weaning from mechanical ventilation

Cardiovascular - Other cardiovascular diseases

Respiratory - Other respiratory disorders / diseases

Intervention(s)

Patients were categorized into 3 groups according to spontaneous breathing trial outcome:
Group I: Heart failure group (heart failure as a cause of weaning failure).
Group II: Respiratory failure group (respiratory cause of weaning failure).
Group III: Success group.
Demographic data, causes of mechanical ventilation and severity score APACHE II (Acute Physiology And Chronic Health Evaluation) score; were recorded at admission to intensive care unit. Clinical, laboratory and echocardiographic data have been obtained immediately before and at the end of the spontaneous breathing trial.
Sample collection and biomarker assays: All arterial blood gases were measured using a blood gas analyzer. BNP and troponin I were measured in venous whole blood by staff blinded to clinical and echocardiographic findings.
Echocardiography
Transthoracic echocardiograms were performed in all patients immediately before and at the end of spontaneous breathing trial. Diastolic function was evaluated with pulse-wave doppler imaging and pulmonary flow measuring blood flow through the mitral valve. Systolic function was assessed in the apical four-chamber view. All echocardiography measurements were performed by cardiologist blinded to the natriuretic peptide, troponin I concentrations and SBT results. Heart failure will be diagnosed by the presence of echocardiography indices suggestive of filling pressures

Primary Outcome(s)

Cardiac biomarkers: B-type natriuretic peptide (nano gram/liter), and troponin I (micro-gram/Liter) concentrations measured using serum assay. [measured before the start of the spontaneous breathing trial (baseline) and at the end of the trial]

Echocardiography indices (a composite primary outcome), including; The left ventricular ejection fraction (EF); the left ventricular end diastolic diameter (LVDTd) in millimeter, the ratio of early to late ventricular filling velocity (E/A ratio).[before the start of the spontaneous breathing trial (baseline) and at the end of the trial]

Respiratory parameters (a composite primary outcome) ; respiratory rate (breaths/minutes), tidal volume (Vt) (mL), respiratory rate/ tidal volume RR/Vt ratio (rapid shallow breathing index) using respiratory monitor.[before the beginning of the spontaneous breathing trial (baseline) and at the end of the trial]

Secondary Outcome(s)

Haemodynamic parameters (a composite secondary outcome); Central venous pressure (CVP) in mmHg, Mean arterial pressure (MAP) in mmHg (using invasive measurement), and heart rate (HR) in beat per minute (using electrocardiogram,ECG), .[before the start of the spontaneous breathing trial (baseline) and at the end of the trial,]

Cumulative fluid balance (using medical records). [was recorded from the time of ICU admission till the day of spontaneous breathing trial; (litre). ]

Arterial blood gases (ABGs) (a composite secondary outcome) including: PH, PaCO2 (mmHg), PaO2 (mmHg), SaO2.(%) by arterial blood samples. [before the beginning of the spontaneous breathing trial (baseline) and at the end of the trial]

Duration of the spontaneous breathing trial (minutes) (using medical records)[Measured from time of starting of spontaneous breathing trial till its end (minutes).]

Secondary ID(s)

nil

Source(s) of Monetary Support

Hoda Alsaid Ahmed Ezz

Secondary Sponsor(s)

Maha Mahmoud Hagras

Ethics review

Status: Approved
Approval date:
Contact:

ethics committee of the faculty of Medicine Tanta University