RBR-6s7rw2 Studies in several research centers on video cardiac surgery

Date of registration: 04/09/2020 ^(mm/dd/yyyy)
Last approval date : 04/09/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: A+33145325809

• Public title:

  en

  Studies in several research centers on video cardiac surgery

  pt-br

  Estudos em diversos centros de pesquisa a respeito da cirurgia cardíaca feita por vídeo

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 23020719.6.0000.5078
    Issuing authority: Plataforma Brasil
  • 3.750.477
    Issuing authority: Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás

Sponsors

• Primary sponsor: Hospital São Francisco de Assis - HSFA
• Secondary sponsor:
  • Institution: Asgard Cursos
• Supporting source:
  • Institution: Hospital São Francisco de Assis - HSFA
  • Institution: Asgard Cursos

Health conditions

• Health conditions:

  en

  cardiovascular surgical procedure

  pt-br

  procedimentos cirúrgicos cardiovasculares

• General descriptors for health conditions:

  en

  C14 Cardiovascular diseases

  pt-br

  C14 Doenças cardiovasculares

  es

  C14 Enfermedades cardiovasculares

• Specific descriptors:

Interventions

• Interventions:

  en

  The efficiency, effectiveness and accuracy of Minimally Invasive Cardiovascular Surgery-MICS. The control or reference standard of the results is represented by a “Gold Standard” test, by the Clinical and Non-Clinical PICOT method, by which the scientific evidence will be evaluated in the present study. MICS Group: one hundred patients with cardiovascular disease will be undergo minimally invasive cardiovascular surgery and the profile of these patients, length of hospital stay and mechanical ventilation as well as the mortality within 30 days after the procedure are checked.

  pt-br

  Eficiência, eficácia e acurácia da Cirurgia Cardiovascular Minimamente Invasiva-MICS. O controle ou padrão de referência dos resultados em estudo é representado por um teste “Padrão Ouro”, pelo método PICOT Clínico e Não Clínico, critérios pelos quais a evidência científica será avaliada no presente estudo. Grupo MICS: 100 pacientes com doença cardiovascular serão submetidos a cirurgia cardiovascular minimamente invasiva e verificados o perfil desses pacientes, tempo de internação e de ventilação mecânica bem como, a mortalidade nos 30 dias após o procedimento

• Descriptors:

  en

  Q65.070 /surgery

  pt-br

  Q65.070 /cirurgia

  es

  Q65.070 /cirugía

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 07/03/2020 ^(mm/dd/yyyy)
• Date last enrollment: 07/03/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  100	-	18 Y	100 -

• Inclusion criteria:

  en

  The sample will consist of 20 (twenty) patients of both sexes; aged at least 18 years old; diagnosed with heart disease, who will evaluate at the Hospital São Francisco de Assis-HSFA, in Goiânia, Goiás for minimally invasive cardiovascular surgery

  pt-br

  A amostra será composta por 20 (vinte) pacientes de ambos os sexos; idade mínima de 18 anos; com diagnóstico de doença cardíaca, que passarão por avaliação no Hospital São Francisco de Assis-HSFA, em Goiânia,Goiás para cirurgia minimamente invasiva

• Exclusion criteria:

  en

  Patients with chest deformities (pectus excavatum) ; diagnosed peripheral atheriopathies patients; Patients with ascending aortic aneurysm; aortic valve insufficiency above IV ; patients with large breasts; obese patients; patients who are undergoing cardiac reoperations

  pt-br

  Pacientes com deformidades acentuadas do tórax (pectus excavatum); ateriopatias periféricas; aneurisma da aorta ascendente; insuficiência valvar aórtica acima de IV; mamas grandes; obesos; reoperações cardíacas

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Other	1	Single-blind	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  to assess the mortality within 30 days after the surgery; little or no mortality rate is expected

  pt-br

  avaliar a mortalidade em 30 dias após o procedimento por meio de contato telefônico; espera-se encontrar pouca ou nenhuma taxa de mortalidade

  en

  to verify the length of stay and mechanical ventilation patients; low values are expected (less than 5 and 2 days, respectively)

  pt-br

  verificar o tempo de internação e ventilação mecânica dos pacientes; espera-se encontrar valores baixos (inferiores a 5 e 2 dias, respectivamente)

  en

  to measure the quality of life by the questionnaire; it is expected to find improvement in the quality of life of patients

  pt-br

  mensurar a qualidade de vida por meio de questionário; espera-se encontrar melhora da qualidade de vida dos pacientes

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Rodrigo Oliveira Rosa Ribeiro de Souza
  • • Address: Rua 9-A, Setor Aeroporto Goiânia
    • City: Goiânia / Brazil
    • Zip code: 74075-250
  • Phone: +55-62-981193295
  • Email: drsouza@gmail.com
  • Affiliation: Hospital São Francisco de Assis
   
• Scientific contact
  • Full name: Rodrigo Oliveira Rosa Ribeiro de Souza
  • • Address: Rua 9-A, Setor Aeroporto Goiânia
    • City: Goiânia / Brazil
    • Zip code: 74075-250
  • Phone: +55-62-981193295
  • Email: drsouza@gmail.com
  • Affiliation: Hospital São Francisco de Assis
   
• Site contact
  • Full name: Rodrigo Oliveira Rosa Ribeiro de Souza
  • • Address: Rua 9-A, Setor Aeroporto Goiânia
    • City: Goiânia / Brazil
    • Zip code: 74075-250
  • Phone: +55-62-981193295
  • Email: drsouza@gmail.com
  • Affiliation: Hospital São Francisco de Assis
   

Additional links:

• Download in ICTRP format