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ETCO₂ Targeting and Cerebral Oxygenation

Does Targeting ETCO₂ Improve Cerebral Oxygenation During Anaesthetic Induction? A Randomized Controlled Trial

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07526077
Enrollment
70
Registered
2026-04-13
Start date
2026-04-10
Completion date
2026-10-13
Last updated
2026-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Reactivity, Hemodynamic Stability During Anesthesia

Keywords

Physiology-guided airway preparation, Standard oxygen therapy, Hemodynamic stability, Cerebral oximetry, Spinal surgery anesthesia

Brief 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).

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.

Interventions

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.

Sponsors

Prince Sultan Military Medical City
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Major spinal surgery * Under general anesthesia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The baseline-to-minimum post-baseline rSO₂ difference,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 intubationThe baseline-to-minimum post-baseline rSO₂ difference, calculated as: T₀ rSO₂ - minimum rSO₂ recorded from T₁ to T₆

Secondary

MeasureTime frameDescription
Incidence of cerebral oxygen desaturationDuring endotracheal intubation≥20% decrease in rSO₂ from baseline

Countries

Saudi Arabia

Contacts

STUDY_DIRECTORMuteb AlOtaibi, MD

Prince Sultan Military Medical City

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 21, 2026