- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Riyadh, Saudiarabien
- Prince Sultan Military Medical City
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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 |
|
Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Oxygen saturation
Tidsram: 3 minutes
|
time from loss of consciousness to SpO₂ reaching 92%
|
3 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
End-tidal Oxygen concentration
Tidsram: 3 minutes
|
the percentage of oxygen measured in the last portion of exhaled breath at the end of expiration.
|
3 minutes
|
|
Mean arterial pressure
Tidsram: 3 minutes
|
Mean arterial pressure
|
3 minutes
|
|
Heart rate
Tidsram: 3 minutes
|
Heart rate
|
3 minutes
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- HP-01-R105
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