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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Riyadh、サウジアラビア
- Prince Sultan Military Medical City
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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 |
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oxygen saturation
時間枠：3 minutes
|
time from loss of consciousness to SpO₂ reaching 92%
|
3 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
End-tidal Oxygen concentration
時間枠：3 minutes
|
the percentage of oxygen measured in the last portion of exhaled breath at the end of expiration.
|
3 minutes
|
|
Mean arterial pressure
時間枠：3 minutes
|
Mean arterial pressure
|
3 minutes
|
|
Heart rate
時間枠：3 minutes
|
Heart rate
|
3 minutes
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HP-01-R105
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Verbal Breathing Coachingの臨床試験
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University of OregonNational Institute of Mental Health (NIMH)募集
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Royal Brompton & Harefield NHS Foundation TrustNational Institute for Health Research, United Kingdom完了
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Boston Medical CenterNational Institute of Mental Health (NIMH)募集