PreoxygenationNCT07565259
Verbal Breathing Coaching to Improve Preoxygenation and Extend Safe Apnea Time in Anesthesia
A study testing Verbal Breathing Coaching in people with Preoxygenation, run by Prince Sultan Military Medical City at 1 site in Saudi Arabia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoxygenation
- What is being tested?
- Verbal Breathing Coaching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 7 Feb 2026to 14 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled for elective surgery under general anesthesia with tracheal intubation.
- BMI < 35 kg/m²
- The Ability to understand and follow verbal instructions
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Preoxygenation
- Being tested
- Verbal Breathing Coaching
- Keywords
- Preoxygenation, Verbal breathing coaching, Safe apnea time, General anesthesia induction, Patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal Breathing CoachingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Standard Preoxygenation | Active comparator | receives standard preoxygenation (routine care with no additional coaching). Receives: Procedure: Verbal Breathing Coaching |
| Intervention Group: Verbal Breathing Coaching | Experimental | receives structured verbal breathing coaching in addition to standard preoxygenation. Receives: Procedure: Verbal Breathing Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
time from loss of consciousness to SpO₂ reaching 92%
Measured: 3 minutes
Secondary outcomes (3)
End-tidal Oxygen concentration
the percentage of oxygen measured in the last portion of exhaled breath at the end of expiration.
Measured: 3 minutes
Mean arterial pressure
Mean arterial pressure
Measured: 3 minutes
Heart rate
Heart rate
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start7 Feb 2026
- Primary completion25 Jun 2026 (estimated)
- Study completion14 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreoxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, parallel-group controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sultan Military Medical City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Daabiss, Prince Sultan Military Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565259
- Sponsor's protocol ID
- HP-01-R105
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Verbal Breathing Coaching During Preoxygenation Prolongs Safe Apnea Time During Induction of General Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07565259
- Acronym / sponsor ID
- HP-01-R105
- Conditions
- Preoxygenation
- Keywords
- Preoxygenation, Verbal breathing coaching, Safe apnea time, General anesthesia induction, Patient safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Prince Sultan Military Medical CityUniversity, hospital or other
- Study start
- 7 Feb 2026 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 14 Jul 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, randomized, parallel-group controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control Group: Standard Preoxygenation | Active comparator | Procedure: Verbal Breathing Coachingreceives standard preoxygenation (routine care with no additional coaching). |
| Intervention Group: Verbal Breathing Coaching | Experimental | Procedure: Verbal Breathing Coachingreceives structured verbal breathing coaching in addition to standard preoxygenation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for elective surgery under general anesthesia with tracheal intubation.
- BMI < 35 kg/m²
- The Ability to understand and follow verbal instructions
Key exclusion criteria (6 listed)
- Patients with an anticipated difficult airway
- Significant cardiopulmonary disease
- Pregnancy
- Emergency surgery
- Pre-existing hypoxemia (SpO₂ < 94% on room air)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal Breathing CoachingIn 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 | Procedure or surgery | Control Group: Standard Preoxygenation, Intervention Group: Verbal Breathing Coaching |
Primary outcome
Oxygen saturation
Time frame: 3 minutes
time from loss of consciousness to SpO₂ reaching 92%
3 secondary outcomes
End-tidal Oxygen concentration
Time frame: 3 minutes
Mean arterial pressure
Time frame: 3 minutes
Heart rate
Time frame: 3 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background1. 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.
- Individual participant dataSharing planned: No
Related trials for Preoxygenation
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
Patient's Experience of Receiving Preoxygenation With the TTIM (Tube Tip in Mouth) Versus the Face Mask
Preoxygenation
Not yet recruiting
Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
Obesity
Not yet recruitingObservational study
Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
Sarcopenia, Handgrip Strength Test
Not yet recruiting
Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
Hypoxemia During Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal Breathing Coaching in people with Preoxygenation, run by Prince Sultan Military Medical City at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07565259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.