Comparison of Double Lumen Tube Placement Techniques
20 de junho de 2018 atualizado por: Igor Zhukov, Emory University
Comparison of Placement of Double-lumen Endobronchial Tube Using GlideScope With 2 Different Stylet Configurations vs Standard Macintosh Laryngoscopy
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
Visão geral do estudo
Status
Rescindido
Condições
Descrição detalhada
The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.
The investigators want to evaluate the technique of placement of the double-lumen endobronchial tube (DLT) using an included stylet that has been radically bent (ZU-bend) as compared to a commercial GlideRite stylet with the GlideScope and direct laryngoscopy using the Macintosh laryngoscope.
A double-lumen endobronchial tube (DLT) is a breathing tube utilized to manage the airway when lung separation is needed for a surgical procedure.
The investigator wants to evaluate how long it takes for successful placement of the double-lumen endobronchial tube (DLT) and assess the difficulty of the procedure experienced by the physician performing the intubation.
Tipo de estudo
Intervencional
Inscrição (Real)
19
Estágio
- Não aplicável
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
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University Hospital Midtown
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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:
- Male and female patients requiring a double-lumen endobronchial tube placement for surgery at Emory University Hospital or Emory University Hospital Midtown
- Patients willing and able to provide written informed consent
Exclusion Criteria:
- Patients in whom a previously difficult airway manipulation was recorded on an anesthetic record
- Lung transplantation procedures, as underlying pulmonary disorder that will confound the SpO2 (peripheral capillary oxygen saturation) metric
- Any patient who is receiving anticoagulants in excess of a daily aspirin, patients with an International Normalized Ratio or INR >1
- Patients in whom one lung ventilation or placement of a double-lumen endobronchial tube is contraindicated
- Patients who require a rapid-sequence intubation
- Patients undergoing emergency procedures
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: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: ZU-bend stylet with GlideScope technique
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
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Laryngoscopy and intubation after induction of anesthesia will be done using the GlideScope and the ZU-bend stylet.
The ZU-bend is a specific shaping technique of the intubating stylet that is closely related to the GlideScope blade curvature.
Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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Comparador Ativo: GlideScope with the GlideRite stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
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Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique.
The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation.
GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
Laryngoscopy and intubation after induction of anesthesia will be done with the GlideScope using the GlideRite stylet.
The GlideRite stylet is specifically designed to work with the GlideScope and provides the necessary rigidity and curvature to an otherwise flexible tube.
GlideRite stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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Comparador Ativo: Macintosh blade and a regular DLT stylet
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
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Direct laryngoscopy and intubation after induction of anesthesia will be done with the Macintosh blade and a regular double-lumen endobronchial tube (DLT) stylet.
The Macintosh blade is used to facilitate visualization of the larynx during double or single lumen endobronchial tube placement.
After intubation the Macintosh laryngoscope is removed and the confirmation of the successful placement of the double-lumen endobronchial tube in done in the standard fashion.
Outros nomes:
Direct laryngoscopy and intubation after induction of anesthesia will be done with a regular double-lumen endobronchial tube (DLT) stylet and the Macintosh blade.
The DLT stylet is withdrawn as a part of placement procedure during the DLT advancement.
Thereafter, Macintosh laryngoscope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
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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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Mean Time to Place the Double-lumen Endobronchial Tube
Prazo: during laryngoscope placement, up to 120 seconds
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The time taken for successful intubation will be recorded by the anesthetist.
The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds.
A higher duration noted is indicative of a longer time taken for successful intubation.
0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)
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during laryngoscope placement, up to 120 seconds
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Success Rate of First Endobronchial Intubation Attempt
Prazo: during laryngoscope placement, up to 120 seconds
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The rate of first intubation attempt success will be recorded by the anesthetist.
A successful first attempt intubation is when the double-lumen endobronchial tube is placed during the initial laryngoscopy within 120 seconds.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
Higher numbers of successful first attempt intubations indicate better rates of success of first endobronchial intubation attempts .
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during laryngoscope placement, up to 120 seconds
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Assessment of Difficulty of Intubation
Prazo: during laryngoscope placement, up to 120 seconds
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The ease of successful placement of the double-lumen endobronchial tube (DLT) will be assessed by the anesthetist's responses to a multi-question form which includes the following items that are scored; overall ease of intubation, laryngoscope insertion, glottic view, double-lumen endobronchial tube (DLT) delivery and placement.
The subjective scores range from 0-10; where 0=worst, 10=best.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
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during laryngoscope placement, up to 120 seconds
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Number of Cases With Complications
Prazo: during laryngoscope placement, up to 120 seconds
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Number of cases with complications during intubation will be will be assessed by the anesthetist's responses to a multi-question form which includes the following items; blood on device, SpO2 (peripheral capillary oxygen saturation) <96%, lip and dental trauma and double-lumen endobronchial tube (DLT) cuff rupture.
The responses are recorded as Yes or No for each item.
A 'yes' response indicates a complication.
The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).
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during laryngoscope placement, up to 120 seconds
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Number of Cases of Voice Change
Prazo: Up to 60 minutes after extubation
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Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by asking the patient if any change in voice is experienced (Yes/No).
The subjective answer given by the patient will be recorded.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
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Up to 60 minutes after extubation
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Throat Pain
Prazo: Up to 60 minutes after extubation
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Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by recording the patient's response to the degree of pain experienced.
An analog pain scale will be used for scoring where: 0= no pain and 10= severe pain.
The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.
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Up to 60 minutes after extubation
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Igor Zhukov, MD, Emory University
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)
27 de julho de 2017
Conclusão do estudo (Real)
27 de julho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
9 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2015
Primeira postagem (Estimativa)
13 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de julho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- IRB00081067
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