Airway ReactivityNCT07526077
ETCO₂ Targeting and Cerebral Oxygenation
An observational study of Airway Reactivity and Hemodynamic Stability During Anesthesia, run by Prince Sultan Military Medical City at 1 site in Saudi Arabia.
Trial summary
This study looked at a safer way to prepare patients for anesthesia before major spinal surgery. Instead of using advanced or complex oxygen devices, the approach will use standard oxygen methods, guided by the patient's individual physiological responses (such as oxygen levels and circulation). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Airway Reactivity, Hemodynamic Stability During Anesthesia
- What is being tested?
- regional cerebral oxygen saturation
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Apr 2026to 13 Oct 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ninety male or female patients, American Society of Anesthesiologists (ASA) I - III
Who may be able to join
- Major spinal surgery
- Under general anesthesia
Who cannot join
- Left ventricular ejection fraction < 35%
- Known intracranial pathology
- Severe pulmonary disease
- Body mass index >40 kg•m-²
- Emergency surgery
- Planned awake intubation
- Known autonomic dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Prince Sultan Military Medical City
Riyadh, Saudi Arabia
About this study
Official title: Does Targeting ETCO₂ Improve Cerebral Oxygenation During Anaesthetic Induction? A Randomized Controlled Trial
This study looked at a safer way to prepare patients for anesthesia before major spinal surgery. Instead of using advanced or complex oxygen devices, the approach will use standard oxygen methods, guided by the patient's individual physiological responses (such as oxygen levels and circulation).
Read the detailed description
We therefore compared conventional mechanical ventilation via a face mask with ventilation adjusted to maintain ETCO₂ at 40-45 mmHg during induction of general anaesthesia for major spinal surgery. We hypothesized that ETCO₂ targeting would reduce the fall in cerebral oxygenation from the post-preoxygenation baseline.
- Being tested
- regional cerebral oxygen saturation
- Keywords
- Physiology-guided airway preparation, Standard oxygen therapy, Hemodynamic stability, Cerebral oximetry, Spinal surgery anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional cerebral oxygen saturationProcedure or surgery
By employing multi-wavelength technology on the forehead, the O3 device provides clinicians with crucial insights into the balance between cerebral oxygen demand and supply. This monitoring is especially valuable for high-risk patient populations, such as those undergoing cardiac surgery, and patients in the intensive care unit (ICU), which provides a continuous, non-invasive assessment of rSO₂ enabling the prompt detection of critical desaturation events. Crucially, changes in rSO₂ during induction correlate with factors directly relevant to spinal cord safety, such as hypotension, hypocapnia, and reduced cardiac output.
| Study group | Role | What they receive |
|---|---|---|
| Group1: Conventional Airway Preparation | Patients will receive preoxygenation via face mask with oxygen at 6-8 L•min-¹. Spontaneous breathing will be maintained until induction, patients will receive conventional mechanical ventilation via a face mask using the anaesthesia ventilator, without a predefined ETCO₂ target. Receives: Procedure: regional cerebral oxygen saturation | |
| Group 2: Physiology-Guided Airway Preparation | Patients will receive face mask preoxygenation as above. patients received mechanical ventilation via a face mask using the same anaesthesia ventilator, with respiratory rate adjusted to maintain ETCO₂ at 40-45 mmHg until tracheal intubation. Receives: Procedure: regional cerebral oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The baseline-to-minimum post-baseline rSO₂ difference,
The baseline-to-minimum post-baseline rSO₂ difference, calculated as:
T₀ rSO₂ - minimum rSO₂ recorded from T₁ to T₆
Measured: MAP will be recorded non-invasively at four specific time points: 1 Baseline (before airway preparation) 2 Immediately before intubation 3 Immediately after intubation 4 Five minutes after intubation
Secondary outcomes (1)
Incidence of cerebral oxygen desaturation
≥20% decrease in rSO₂ from baseline
Measured: During endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start10 Apr 2026
- Primary completion12 Oct 2026 (estimated)
- Study completion13 Oct 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 Airway ReactivityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
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
- Investigators
- Muteb AlOtaibi, MD, Study director, Prince Sultan Military Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526077
- Sponsor's protocol ID
- HP-01-R085
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Casati A, et al. Cerebral oximetry in spinal surgery: a practical approach. Br J Anaesth. 2007;99:99-104. 2. Slater JP, et al. Cerebral oxygen desaturation predicts cognitive decline after cardiac surgery. Anesth Analg. 2009;108:120-127. 3. Hara K, et al. Near-infrared spectroscopy for cerebral monitoring in prone spinal surgery. Spine. 2013;38:E1231-E1238.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Targeting ETCO₂ Improve Cerebral Oxygenation During Anaesthetic Induction? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07526077
- Acronym / sponsor ID
- HP-01-R085
- Keywords
- Physiology-guided airway preparation, Standard oxygen therapy, Hemodynamic stability, Cerebral oximetry, Spinal surgery anesthesia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Prince Sultan Military Medical CityUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 13 Apr 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 looked at a safer way to prepare patients for anesthesia before major spinal surgery. Instead of using advanced or complex oxygen devices, the approach will use standard oxygen methods, guided by the patient's individual physiological responses (such as oxygen levels and circulation).
Detailed description
We therefore compared conventional mechanical ventilation via a face mask with ventilation adjusted to maintain ETCO₂ at 40-45 mmHg during induction of general anaesthesia for major spinal surgery. We hypothesized that ETCO₂ targeting would reduce the fall in cerebral oxygenation from the post-preoxygenation baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: Conventional Airway Preparation | – | Procedure: regional cerebral oxygen saturationPatients will receive preoxygenation via face mask with oxygen at 6-8 L•min-¹. Spontaneous breathing will be maintained until induction, patients will receive conventional mechanical ventilation via a face mask using the anaesthesia ventilator, without a predefined ETCO₂ target. |
| Group 2: Physiology-Guided Airway Preparation | – | Procedure: regional cerebral oxygen saturationPatients will receive face mask preoxygenation as above. patients received mechanical ventilation via a face mask using the same anaesthesia ventilator, with respiratory rate adjusted to maintain ETCO₂ at 40-45 mmHg until tracheal intubation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ninety male or female patients, American Society of Anesthesiologists (ASA) I - III
Key inclusion criteria (2 listed)
- Major spinal surgery
- Under general anesthesia
Key exclusion criteria (7 listed)
- Left ventricular ejection fraction < 35%
- Known intracranial pathology
- Severe pulmonary disease
- Body mass index >40 kg•m-²
- Emergency surgery
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 |
|---|---|---|
| regional cerebral oxygen saturationBy employing multi-wavelength technology on the forehead, the O3 device provides clinicians with crucial insights into the balance between cerebral oxygen demand and supply. This monitoring is especially valuable for high-risk patient populations, such as those undergoing cardiac surgery, and patients in the intensive care unit (ICU), which provides a continuous, non-invasive assessment of rSO₂ enabling the prompt detection of critical desaturation events. Crucially, changes in rSO₂ during induction correlate with factors directly relevant to spinal cord safety, such as hypotension, hypocapnia, and reduced cardiac output. | Procedure or surgery | Group 2: Physiology-Guided Airway Preparation, Group1: Conventional Airway Preparation |
Primary outcome
The baseline-to-minimum post-baseline rSO₂ difference,
Time frame: MAP will be recorded non-invasively at four specific time points: 1 Baseline (before airway preparation) 2 Immediately before intubation 3 Immediately after intubation 4 Five minutes after intubation
The baseline-to-minimum post-baseline rSO₂ difference, calculated as: T₀ rSO₂ - minimum rSO₂ recorded from T₁ to T₆
1 secondary outcome
Incidence of cerebral oxygen desaturation
Time frame: During endotracheal intubation
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 20 Oct 2026.
- Background1. Casati A, et al. Cerebral oximetry in spinal surgery: a practical approach. Br J Anaesth. 2007;99:99-104. 2. Slater JP, et al. Cerebral oxygen desaturation predicts cognitive decline after cardiac surgery. Anesth Analg. 2009;108:120-127. 3. Hara K, et al. Near-infrared spectroscopy for cerebral monitoring in prone spinal surgery. Spine. 2013;38:E1231-E1238.
- Individual participant dataSharing planned: No
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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.
Muteb AlOtaibi, MD study director
Prince Sultan Military Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Reactivity and Hemodynamic Stability During Anesthesia, 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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 20 Oct 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?
The baseline-to-minimum post-baseline rSO₂ difference, (time frame: MAP will be recorded non-invasively at four specific time points: 1 Baseline (before airway preparation) 2 Immediately before intubation 3 Immediately after intubation 4 Five minutes after intubation). 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 NCT07526077, 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 20 Oct 2026.