Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
16 de setembro de 2016 atualizado por: Todd Rice, Vanderbilt University
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Endotracheal intubation is common in the care of critically ill patients.
Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death.
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
Tipo de estudo
Intervencional
Inscrição (Real)
260
Estágio
- Fase 4
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
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama - Birmingham
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70115
- Ochsner Medical Center
-
New Orleans, Louisiana, Estados Unidos, 70112
- Louisiana State University School of Medicine
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98104
- University of Washington
-
-
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
Descrição
Inclusion Criteria:
Airway management events will be included in which:
- Patient is admitted to the Medical Intensive Care Unit (MICU)
- Planned procedure is endotracheal intubation
- Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
Airway management events will be excluded in which:
- Operator feels specific patient positioning during intubation is required
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an alternative pre-procedure checklist or no checklist is required
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
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
|
|
|
Comparador Ativo: Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
|
Use of a written checklist pre and peri-intubation
Outros nomes:
|
|
Comparador Ativo: Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
|
Raising the patient's head of bed to 25 degrees
Outros nomes:
|
|
Comparador Ativo: Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
|
Use of a written checklist pre and peri-intubation
Outros nomes:
Raising the patient's head of bed to 25 degrees
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Prazo: Time of Induction through 2 minutes after successful intubation
|
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
|
Time of Induction through 2 minutes after successful intubation
|
|
Lowest Systolic Blood Pressure (Checklist intervention only)
Prazo: Time of Induction through 2 minutes after successful intubation
|
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
|
Time of Induction through 2 minutes after successful intubation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Desaturation
Prazo: Time of Induction through 2 minutes after successful intubation
|
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
|
Time of Induction through 2 minutes after successful intubation
|
|
Incidence of Hypoxemia
Prazo: Time of Induction through 2 minutes after successful intubation
|
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
|
Time of Induction through 2 minutes after successful intubation
|
|
Change in Saturation
Prazo: Time of Induction through 2 minutes after successful intubation
|
Change in oxygen saturation from baseline to lowest oxygen saturation
|
Time of Induction through 2 minutes after successful intubation
|
|
Grade of First Glottic View
Prazo: Time of Induction through 2 minutes after successful intubation
|
Cormack-Lehane grade of view on first intubation attempt
|
Time of Induction through 2 minutes after successful intubation
|
|
First Pass Success
Prazo: Time of Induction through 2 minutes after successful intubation
|
Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
|
Time of Induction through 2 minutes after successful intubation
|
|
Number of Intubation Attempts
Prazo: Time of Induction through 2 minutes after successful intubation
|
Number of attempts required for successful tube placement
|
Time of Induction through 2 minutes after successful intubation
|
|
Time to Intubation
Prazo: Time of Induction through 2 minutes after successful intubation
|
Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
|
Time of Induction through 2 minutes after successful intubation
|
|
Need for Assistance
Prazo: Time of Induction through 2 minutes after successful intubation
|
Incidence of need for additional intubating equipment, second operator
|
Time of Induction through 2 minutes after successful intubation
|
|
Non-hypoxic complications
Prazo: Time of Induction through 2 minutes after successful intubation
|
Incidence of non-oxygenation complications - composite of all other recorded complications
|
Time of Induction through 2 minutes after successful intubation
|
|
Malposition of Endotracheal Tube
Prazo: Time of Induction through 2 minutes after successful intubation
|
Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
|
Time of Induction through 2 minutes after successful intubation
|
|
Repositioning Patient
Prazo: Time of Induction through 2 minutes after successful intubation
|
Incidence of repositioning patient after procedure initiation
|
Time of Induction through 2 minutes after successful intubation
|
|
In-Hospital Mortality
Prazo: From enrollment through the earlier of hospital discharge or 365 days
|
Death before hospital discharge
|
From enrollment through the earlier of hospital discharge or 365 days
|
|
Ventilator-free Days
Prazo: From enrollment through study day 28
|
Days alive and free from mechanical ventilation
|
From enrollment through study day 28
|
|
ICU-Free Days
Prazo: From enrollment through study day 28
|
Days alive and out of the ICU
|
From enrollment through study day 28
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Todd W Rice, MD, MSc, Vanderbilt University Medical Center
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
- Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
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
1 de julho de 2015
Conclusão Primária (Real)
1 de setembro de 2016
Conclusão do estudo (Real)
1 de setembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
6 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2015
Primeira postagem (Estimativa)
14 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
19 de setembro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de setembro de 2016
Última verificação
1 de setembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 150897
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 .