此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Verbal Breathing Coaching to Improve Preoxygenation and Extend Safe Apnea Time in Anesthesia

2026年4月27日 更新者:Mohamed Daabiss、Prince Sultan Military Medical City

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.

研究概览

地位

主动,不招人

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Riyadh、沙特阿拉伯
        • Prince Sultan Military Medical City

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器: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

实验性的: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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Oxygen saturation
大体时间:3 minutes
time from loss of consciousness to SpO₂ reaching 92%
3 minutes

次要结果测量

结果测量
措施说明
大体时间
End-tidal Oxygen concentration
大体时间:3 minutes
the percentage of oxygen measured in the last portion of exhaled breath at the end of expiration.
3 minutes
Mean arterial pressure
大体时间:3 minutes
Mean arterial pressure
3 minutes
Heart rate
大体时间:3 minutes
Heart rate
3 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 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.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月7日

初级完成 (估计的)

2026年6月25日

研究完成 (估计的)

2026年7月14日

研究注册日期

首次提交

2026年4月10日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅