Clinical trial NCT03037333: Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
Official title: Prospective Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bradycardia
Keywords: echocardiogram
Electrocardiogram: Electrical Alternans
fluoroscopy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A lot of questions about use of temporary transvenous pacing still remain obscure and there is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram in patients with bradicardias. The aim of the study is to evaluate how long does it take to start the correct cardiac stimulation with transvenous pacing in patients with bradicardias comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of complications between two methods.

Detailed description: Approximately 150 subjects will be recruited over a planned recruitment period of 18 months. Patients will be submitted to ecchocardiogram using Philips Envisor, and electrocardiogram with Philips Healthcare PageWriter TC30.

Eligibility criteria: Inclusion Criteria:

* adult males and females aged \> 18 years
* symptomatic bradicardia
* informed consent signed.

Exclusion Criteria:

* pregnancy
* hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmHg)
* body mass index greater than 40 kg/ m2
* use of oral anticoagulation
* acute coronary syndromes
* left ventricle ejection fraction \< 45%
* presence of any kind of cardiac stimulation device

Primary outcomes:
measure: all cause mortality
timeFrame: 1 week
measure: infection
timeFrame: 1 week
measure: hematoma > 5 cm
timeFrame: 1 week
measure: cardiac perforation
timeFrame: 1 week
measure: pneumothorax
timeFrame: 1 week
measure: ventricular tachycardia
timeFrame: 1 week
measure: loss of capture
timeFrame: 1 week
measure: venous thrombosis
timeFrame: 1 week
measure: any complication the delays definitive pacemaker > 48 hours
timeFrame: 1 week
Secondary outcomes:
measure: Time to start the correct cardiac stimulation with transvenous pacing
timeFrame: 1 week
measure: rates of success
timeFrame: 1 week
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HMFMUSP
state: SP
Study officials:
affiliation: Unidade Clínica de Emergência
name: Alexandre Soeiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23.
citation: Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245.
citation: Bouaziz H, Zetlaoui PJ, Pierre S, Desruennes E, Fritsch N, Jochum D, Lapostolle F, Pirotte T, Villiers S. Guidelines on the use of ultrasound guidance for vascular access. Anaesth Crit Care Pain Med. 2015 Feb;34(1):65-9. doi: 10.1016/j.accpm.2015.01.004. Epub 2015 Mar 5.