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- Ensaio Clínico NCT03340038
Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps (ICU)
Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps: A Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Free flaps are an instrumental component of head and neck reconstructive surgery. There is no current consensus on the postoperative management of these patients despite the increasing frequency with which free flaps are used. Although patients often do not have a specific medical indication for postoperative ICU management, they frequently are sent to the ICU for postoperative care based on the need for close nurse monitoring of the flap. In a US based survey in 2007, 88.9% of head and neck surgeons were sending postoperative flap patients to the ICU. Typical ICU length of stay for these patients varies from 2-11 days. There are numerous theoretic disadvantages to ICU care in these patients. ICU care has been associated with increased use of sedation leading to decreased flap perfusion, prolonged use of ventilation, less self care, less ambulation, increased delirium and increased cost.
Due to these concerns, several institutions have developed protocols that allow for the monitoring of head and neck free-flap patients outside of the ICU. Two recent retrospective studies assessed outcomes using these protocols, including 257 patients (119 ICU, 138 ward) and showed no significant difference in morbidity and mortality, or flap failure between the groups. There was a significant increase LOS from 8 to 9 days and transfusion rate, in the ICU group. Another study looked at 247 patients (175 ICU, 72 ward) and found no difference between flap failure, reoperation, hematoma, wound complications between the groups. They also found an increased LOS from 7 to 8 days in the ICU group. They calculated cost difference and found a decrease in average patient cost from $101,199 to $86,195 in the ward group. These studies support the use of non-ICU care for head and neck free-flap patients, however given their retrospective nature significant biases may exist, tempering the strength of their conclusions. To date, there has never been a Randomized Controlled Trial (RCT) that addresses this question.
This is a non-inferiority RCT at UCDMC to assess differences in LOS, complication rate and resource utilization between patients randomized to the ICU and a head and neck specialty ward. Since ICU/Ward bed availability has to be determined before surgery, a subject will be randomized before surgery when the subject meets all inclusion and none of the exclusion criteria. Currently, postoperative flap patients who are not enrolled in the study at UCDMC are monitored in the ICU for a minimum of 24 hours following their surgery.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Sacramento, California, Estados Unidos, 95817
- University of California, Davis
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients undergoing free flaps for reconstruction of head and neck surgical defects at UCDMC, including but not limited to, head and neck cancer defects, osteoradionecrosis (ORN), and trauma
- 18 years of age and older and able to consent
Exclusion Criteria:
- Vulnerable populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Specialty Ward
Patients who have been randomized into receiving post-operative care at the Non-ICU Specialty ward (intervention) after receiving flap reconstructive surgery on their mucosal or cutaneous defect.
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|
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Sem intervenção: Intensive Care Unit (ICU)
Patients who have been randomized into receiving post-operative care at the intensive care unit after receiving flap reconstructive surgery on their mucosal or cutaneous defect.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Length of Stay
Prazo: 30 days
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Number of days
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30 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Inpatient Hospital Costs (dollar amounts)
Prazo: 30 days
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Total inpatient hospital cost, insurance adjustments, and payments
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30 days
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Post Operative Complication Rate
Prazo: 30 days
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Flap ischemia, Reopration, Hematoma, wound infection, flap loss, and other complications
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30 days
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Medical Complications
Prazo: 30 days
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Pneumonia, thromboembolic event, sepsis, ventilator requirement, cardiovascular complication, poster operative transfusion, delirium, ICU admission, other complications, mortality, readmission status
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30 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arnaud Bewley, MD, University of California, Davis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 841511
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