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Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Lausanne ICU

2 de junho de 2022 atualizado por: Piquilloud Imboden Lise

Analysis of Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Intensive Care Unit of the Lausanne University Hospital

This retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

80

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Suíça
    • Vaud
      • Lausanne, Vaud, Suíça, 1011
        • Lausanne University hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

All patients admitted to the Lausanne ICU between May1st and November 31st who had a tracheotomy and were ventilated for more than 72 hours were screened for exclusion criterias. 147 patients were screened and 80 patients were included.

Descrição

Inclusion Criteria:

  • All patients hospitalized in the Lausanne ICU between May 1st 2017 and November 31st 2018 with a tracheotomy and mechanically ventilated more than 72 hours.

Exclusion Criteria:

  • Presence of a know opposition to participation to research projects
  • Patient tracheostomized specifically for ENT (ear-nose-throat) reason
  • Burn victim
  • Patient tracheostomized before his/her admission to the Lausanne ICU

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intubation for respiratory reasons
All patients who were intubated for respiratory reasons (i.e. acute respiratory distress syndrome, pneumonias, pleural effusions for example)
Intubation for neurological reasons
All patients who were intubated for neurological reasons (i.e. stroke, intracranial bleeding, cervical fracture with tetraparesia for example)
Intubation for other reasons
All patients who were intubated for other reasons than respiratory or neurological (i.e. intubation before surgery, cardiac arrest, hemodynamic instability and polytraumatism without respiratory distress or neurological pathology necessitating intubation)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Time from intubation to tracheotomy
Prazo: Once, between time of intubation to time of tracheotomy, up to 60 days
Calculated from clinical information system (time of intubation, time of tracheotomy), calculated in hours
Once, between time of intubation to time of tracheotomy, up to 60 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Age
Prazo: At ICU admission
Collected from electronic patient files.
At ICU admission
Weight
Prazo: At ICU admission
Collected from electronic patient files.
At ICU admission
Height
Prazo: At ICU admission
Collected from electronic patient files.
At ICU admission
Body mass index
Prazo: At ICU admission
Calculated from weight and height
At ICU admission
Predicted body weight (PBW)
Prazo: At ICU admission

Calculated as such :

Adult male: 50 + 0.91 (Height cm -152.4) / Adult female: 45 + 0.91 (Height cm -152.4)
At ICU admission
SOFA score (admission)
Prazo: At ICU admission
Calculated at admission
At ICU admission
Clinical Frailty Score
Prazo: At ICU admission
Calculated at ICU admission
At ICU admission
Charlson comorbidity index
Prazo: At ICU admission
Calculated at ICU admission
At ICU admission
Comorbidities
Prazo: At ICU admission
Collected at ICU admission
At ICU admission
Ventilation modalities and settings from intubation to tracheotomy
Prazo: Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days
Ventilation modalities and settings recolted from electronic patient files.
Once every day at 8am, between day after intubation to day before tracheotomy, up to 60 days
Sedation opioid use from intubation to tracheotomy
Prazo: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Sedation use collected from electronic patient files.
Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Opioid use from intubation to tracheotomy
Prazo: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Opioid use collected from electronic patient files.
Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Neuromuscular blocking agent use from intubation to tracheotomy
Prazo: Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Neuromuscular blocking agent use collected from electronic patient files.
Once every day at 8am and at time of minimal and maximal value, between day of intubation to day of tracheotomy, up to 60 days
Tracheotomy time
Prazo: At time of tracheotomy, once, up to 60 days after intubation day
Collected from electronic patient files (day and hour)
At time of tracheotomy, once, up to 60 days after intubation day
Tracheotomy type (percutaneous, surgical)
Prazo: At time of tracheotomy, once, up to 60 days after intubation day
Collected from electronic patient files.
At time of tracheotomy, once, up to 60 days after intubation day
Ventilation settings and modalities from day of tracheotomy
Prazo: 2 hours before tracheotomy
Collected from electronic patient files.
2 hours before tracheotomy
SOFA score (tracheotomy day)
Prazo: Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day
Calculated from electronic patient files.
Once, on the day of tracheotomy (worst value of the day of tracheotomy), up to 60 days after intubation day
Ventilation modalities and settings from tracheotomy to mechanical ventilation weaning
Prazo: Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days
Ventilation modalities and settings collected from electronic patient files.
Once per day, from day of tracheotomy to mechanical ventilation weaning, up to 60 days
Tracheotomy weaning strategies from tracheotomy to mechanical ventilation weaning
Prazo: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Data collected from electronic patient files.
Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Physical therapy sessions from tracheotomy to mechanical ventilation weaning
Prazo: Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Data collected from electronic patient files.
Once every day at 8am and at time of minimal and maximal value, from day of tracheotomy to day of mechanical ventilation weaning, up to 31 days
Mechanical ventilation weaning day
Prazo: Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day
Data collected from electronic patient files.
Once (day 3 in a row of less than 12 hours of mechanical ventilation), up to 31 days after tracheotomy day
SOFA score (mechanical ventilation weaning day)
Prazo: Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day
Calcutated from electronic patient files.
Once (3rd consecutive day with less than 12-h of mechanical ventilation), up to 31 days after tracheotomy day
Ventilation modalities and settings from mechanical ventilation weaning day to decannulation or ICU discharge or death
Prazo: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Collected from electronic patient files.
Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Physical therapy sessions from mechanical ventilation weaning day to decannulation or ICU discharge or death
Prazo: Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Collected from electronic patient files.
Once every day at 8am and at time of minimal and maximal value, from day of mechanical ventilation weaning to decannulation or ICU discharge or death, up to 31 days
Hospital stay duration
Prazo: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Collected from electronic patient files and discharge letters
Once, between day of hospital admission to day of hospital discharge, up to 2 years
Outcome and specific treatments in ICU
Prazo: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Data recolted from electronic patient files
Once, between day of hospital admission to day of hospital discharge, up to 2 years
Correlation of ventilation settings and modalities and tracheotomy weaning strategies
Prazo: Once, between day of hospital admission to day of hospital discharge, up to 2 years
Collected from electronic patient files and discharge letters
Once, between day of hospital admission to day of hospital discharge, up to 2 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Piquilloud Imboden Lise

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de junho de 2021

Conclusão Primária (Real)

15 de maio de 2022

Conclusão do estudo (Real)

15 de maio de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

12 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de agosto de 2021

Primeira postagem (Real)

3 de agosto de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de junho de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de junho de 2022

Última verificação

1 de agosto de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TRACH-CHANGE

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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