Physiology-Guided Airway Preparation Enhances Hemodynamics and Cerebral Oxygenation

NCT07526077 | Enrolling By Invitation DMC

• 1 other identifier: HP-01-R085
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Airway Reactivity; Hemodynamic Stability During Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• MAP variability during induction

  Maximum percentage decrease in MAP from baseline between induction and intubation

  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

  During endotracheal intubation

Study Arms (3)

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, and manual ventilation will be performed at the discretion of the attending anesthesiologist without predefined EtCO₂ targets.

Procedure: regional cerebral oxygen saturation

Group 2: Structured Conventional Airway Preparation

Patients will receive identical preoxygenation. Following induction, gentle assisted ventilation will be initiated to maintain EtCO₂ between 35 and 40 mmHg, avoiding hyperventilation.

Procedure: regional cerebral oxygen saturation

Group 3: Physiology-Guided Airway Preparation

Patients will receive face mask preoxygenation as above. A low-flow nasal cannula delivering oxygen at 5 L•min-¹ will be maintained during laryngoscopy. Manual ventilation will be adjusted to achieve an EtCO₂ target of 40-45 mmHg, representing mild permissive hypercapnia.

Procedure: regional cerebral oxygen saturation

Interventions

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.

Group 2: Structured Conventional Airway Preparation; Group 3: Physiology-Guided Airway Preparation; Group1: Conventional Airway Preparation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Male or female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ninety male or female patients, American Society of Anesthesiologists (ASA) I - III

You may qualify if:

• Major spinal surgery
• Under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince Sultan Military Medical City: lead

Study Sites (1)

Prince Sultan Military Medical City

Riyadh, Saudi Arabia

Location

Related Publications (1)

• 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.

  BACKGROUND

Study Officials

• Muteb AlOtaibi, MD

  Prince Sultan Military Medical City

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesia

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)