Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia (PRIOR-Trauma)
Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study
Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.
It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.
Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.
Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.
The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Malin Jonsson Fagerlund
- Número de telefone: 0707691405
- E-mail: malin.jonsson-fagerlund@sll.se
Locais de estudo
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Stockholm, Suécia, SE-17176
- Recrutamento
- Karolinska University Hospital Solna
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Contato:
- Malin Jonsson Fagerlund
- Número de telefone: +46707691405
- E-mail: malin.jonsson.fagerlund@ki.se
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Critérios de participação
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Descrição
Inclusion Criteria:
- 1 Adult, ≥18 years old
- 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).
Exclusion Criteria:
- 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Tight fitting facemask
Preoxygenation with tight facemask, 100% oxygen.
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Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
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High flow nasal oxygen
Preoxygenation with high flow nasal oxygen, 100% oxygen
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Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.
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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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Number of patients with a peripheral oxygen saturation (SpO2) below 93%
Prazo: From start of anaesthesia until 1 minute after tracheal intubation.
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Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.
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From start of anaesthesia until 1 minute after tracheal intubation.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Lowest median SpO2.
Prazo: From start of anaesthesia until 1 minute after tracheal intubation.
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Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation
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From start of anaesthesia until 1 minute after tracheal intubation.
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End tidal gas levels
Prazo: At the first breath after tracheal intubation.
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Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.
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At the first breath after tracheal intubation.
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Time span from start of preoxygenation until intubation.
Prazo: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.
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Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Time span from entering trauma room until intubation.
Prazo: Could vary depending on patient and trauma, from a couple of minutes up to an hour.
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Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.
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Could vary depending on patient and trauma, from a couple of minutes up to an hour.
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Difficulties with induction of anaesthesia
Prazo: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula
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Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Frequency of complications
Prazo: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Frequency of complications (aspiration, signs of intraabdominal/intracranial gas, difficulties intubating the trachea, hypotension) in the HFNO group compared to the group preoxygenated with traditional facemask.
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Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Malin Jonsson Fagerlund, Karolinska University Hospital and Karolinska Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PRIOR-Trauma
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