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临床试验/NCT07565259
NCT07565259进行中(未招募)不适用

Structured Verbal Breathing Coaching During Preoxygenation Prolongs Safe Apnea Time During Induction of General Anesthesia: a Randomized Controlled Trial

Prince Sultan Military Medical City1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
1
主要终点
Oxygen saturation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

Participants will be randomized into a two equal groups each will be 60 participants, using a computer-generated random sequence. Allocation will be concealed in sealed opaque envelopes opened immediately before preoxygenation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for elective surgery under general anesthesia with tracheal intubation.
  • BMI < 35 kg/m²
  • The Ability to understand and follow verbal instructions

排除标准

  • 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.

研究组 & 干预措施

Control Group: Standard Preoxygenation

Active Comparator

receives standard preoxygenation (routine care with no additional coaching).

干预措施: Verbal Breathing Coaching (Procedure)

Intervention Group: Verbal Breathing Coaching

Experimental

receives structured verbal breathing coaching in addition to standard preoxygenation.

干预措施: Verbal Breathing Coaching (Procedure)

结局指标

主要结局

Oxygen saturation

时间窗: 3 minutes

time from loss of consciousness to SpO₂ reaching 92%

次要结局

  • End-tidal Oxygen concentration(3 minutes)
  • Mean arterial pressure(3 minutes)
  • Heart rate(3 minutes)

研究者

发起方
Prince Sultan Military Medical City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Daabiss

CONSULTANT ANESTHESIA, Principal Investigator

Prince Sultan Military Medical City

研究点 (1)

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