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Enrolling by Invitation

NCT Number: NCT07526077

Physiology-Guided Airway Preparation Enhances Hemodynamics and Cerebral Oxygenation

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 used standard oxygen methods, guided by the patient's individual physiological responses (such as oxygen levels and circulation).

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Key information

Conditions

Airway Reactivity Hemodynamic Stability During Anesthesia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Sultan Military Medical City

Riyadh, Saudi Arabia

About this study

We proposed that a physiology-guided airway preparation approach, relying solely on conventional oxygen delivery methods, would enhance haemodynamic stability and cerebral oxygenation during anaesthetic induction in patients undergoing major spinal surgery. The findings are intended to improve patient safety, support better intraoperative decision-making, and potentially encourage wider integration of cerebral oximetry into perioperative neuroprotection strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

regional cerebral oxygen saturation

Procedure

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.

Primary outcomes

  1. MAP variability during induction

    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

    Maximum percentage decrease in MAP from baseline between induction and intubation

Secondary outcomes

  1. Incidence of cerebral oxygen desaturation

    Time frame: During endotracheal intubation

    ≥20% decrease in rSO₂ from baseline

Sponsors and collaborators

Lead sponsor

Prince Sultan Military Medical City

Other

Registry information

Official study title

Physiology-Guided Airway Preparation Using Standard Oxygen Therapy Improves Hemodynamic Stability and Cerebral Oxygenation During Induction of Anesthesia for Major Spinal Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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