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- Ensaio Clínico NCT07565259
Verbal Breathing Coaching to Improve Preoxygenation and Extend Safe Apnea Time in Anesthesia
Structured Verbal Breathing Coaching During Preoxygenation Prolongs Safe Apnea Time During Induction of General Anesthesia: a Randomized Controlled Trial
This study explores whether simply guiding patients to breathe slowly and calmly before anesthesia can help improve oxygen levels and keep them safe for longer during induction.
The investigators included 120 participants scheduled for elective surgery, comparing routine preoxygenation with a gentle, coached breathing technique using steady inhalation and exhalation.
The investigator focused mainly on how long participants could safely tolerate apnea, while also examining oxygen levels, vital signs, and anxiety.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study looks at a simple but meaningful question: can the way the investigators talk to participants-and guide their breathing-make anesthesia safer? Before induction, participants are usually asked to breathe oxygen through a mask, but many do so in a shallow or irregular way due to anxiety or lack of guidance. Here, the investigators introduce a calm, structured approach where participants are gently coached to take slow, deep breaths with controlled inhalation and prolonged exhalation, helping them feel more relaxed and engaged in their own care.
the investigators included 120 adult participants scheduled for elective surgery, all relatively healthy (ASA I-II), and divided them into two groups. One group received the usual instructions to "breathe normally," while the other group was guided step-by-step with simple verbal cues to regulate their breathing pattern. This small change transforms a passive process into an active, patient-centered interaction, potentially improving how effectively oxygen fills the lungs before anesthesia.
the investigators main focus is on "safe apnea time"-how long a patient can maintain adequate oxygen levels after induction before desaturation begins. the investigators also look at additional factors such as oxygen concentration at the end of preoxygenation, changes in blood pressure and heart rate, and even how anxious the participant feels before going to sleep. These measures help the investigators understand not only the physiological benefits but also the emotional impact of this approach.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Riyadh, Arábia Saudita
- Prince Sultan Military Medical City
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Scheduled for elective surgery under general anesthesia with tracheal intubation.
- BMI < 35 kg/m²
- The Ability to understand and follow verbal instructions
Exclusion Criteria:
- Patients with an anticipated difficult airway
- Significant cardiopulmonary disease
- Pregnancy
- Emergency surgery
- Pre-existing hypoxemia (SpO₂ < 94% on room air)
- Use of sedative premedication affects respiratory drive.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Control Group: Standard Preoxygenation
receives standard preoxygenation (routine care with no additional coaching).
|
In addition to standard preoxygenation, patients receive continuous verbal coaching: "Breathe in slowly through your nose for four seconds" "Now breathe out slowly through your mouth for six seconds" Instructions repeated rhythmically for 3 minutes Delivered by the attending anesthesiologist using a standardized script |
|
Experimental: Intervention Group: Verbal Breathing Coaching
receives structured verbal breathing coaching in addition to standard preoxygenation.
|
In addition to standard preoxygenation, patients receive continuous verbal coaching: "Breathe in slowly through your nose for four seconds" "Now breathe out slowly through your mouth for six seconds" Instructions repeated rhythmically for 3 minutes Delivered by the attending anesthesiologist using a standardized script |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Oxygen saturation
Prazo: 3 minutes
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time from loss of consciousness to SpO₂ reaching 92%
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3 minutes
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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End-tidal Oxygen concentration
Prazo: 3 minutes
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the percentage of oxygen measured in the last portion of exhaled breath at the end of expiration.
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3 minutes
|
|
Mean arterial pressure
Prazo: 3 minutes
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Mean arterial pressure
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3 minutes
|
|
Heart rate
Prazo: 3 minutes
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Heart rate
|
3 minutes
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 1. Nimmagadda, U., Salem, M.R., & Joseph, N.J. (2000). Preoxygenation: physiologic basis, benefits, and potential risks. Anesthesiology Clinics of North America, 18(3), 547-563. 2. Tanoubi, I., Drolet, P., & Donati, F. (2009). Optimizing preoxygenation in adults. Canadian Journal of Anesthesia, 56(6), 449-466. 3. Baraka, A., Taha, S.K., El-Khatib, M.F. (1999). Preoxygenation: comparison of maximal breathing and tidal volume breathing techniques. Anesthesia & Analgesia, 89(3), 653-656. 4. Gambee, A.M., Hertzka, R.E., & Fisher, D.M. (1987). Preoxygenation techniques: comparison of three minutes tidal volume breathing and eight deep breaths over 60 seconds. Anesthesiology, 66(6), 816-819. 5. O'Brien, J., Batterham, A.M., & Parkin, P. (2011). Coaching respiratory techniques improves gas exchange and tidal volume during voluntary breathing tasks. Respiration Physiology & Neurobiology, 177(2), 153-158. 6. Weingart, S.D., Levitan, R.M. (2012). Preoxygenation and prevention of desaturation during emergency airway management. Annals of Emergency Medicine, 59(3), 165-175.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Outros números de identificação do estudo
- HP-01-R105
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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