Manual Versus Autoflow Ventilation During Anesthesia Inductıon in Geriatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAnkara City Hospital Bilkent
About this trial
The objective of this study is to compare the effects of manual ventilation and AutoFlow ventilation, administered during the induction of general anesthesia, on cerebral (s-rSO₂) and peripheral (somatic) oxygenation (p-rSO₂) in geriatric patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 65 years and older.
Patients scheduled to undergo elective surgery requiring endotracheal intubation under general anesthesia.
Patients with an American Society of Anesthesiologists (ASA) physical status of I, II, or III.
Volunteer patients who are willing to participate and provide written informed consent.
Disqualifiers
Patients with severe heart failure or severe pulmonary disease.
Patients with a presence or history of brain tumors or cerebrovascular accidents (CVA/stroke).
Patients with impaired cooperation or cognitive dysfunction (e.g., dementia, delirium, Alzheimer's disease).
Patients with a known history or preoperative prediction of a difficult airway.
Trial design
Design model
Parallel
Treatments tested in this trial
Manual Mask Ventilation
Procedure/SurgeryPatients will receive manual mask ventilation with 100% oxygen using a reservoir bag. This procedure will be performed by an experienced anesthesiologist or anesthesia resident for 2 minutes following the administration of induction agents, allowing for adequate muscle relaxation prior to endotracheal intubation.
AutoFlow Mechanical Mask Ventilation
Procedure/SurgeryPatients will receive mask ventilation delivered mechanically by the anesthesia workstation. The device will provide 100% oxygen for 2 minutes following the administration of induction agents. The ventilator settings will be standardized to an AutoFlow mode with a tidal volume (VT) of 6 mL/kg (based on ideal body weight), a respiratory rate of 12 breaths/minute, a peak pressure limit of 30 cmH₂O, and a Positive End-Expiratory Pressure (PEEP) of 5 cmH₂O
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Group M (Manual Ventilation)Active comparator 1 intervention
Group B: Group A (AutoFlow Ventilation)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Cerebral Regional Oxygen Saturation (s-rSO2)
Bilateral cerebral regional oxygen saturation will be continuously measured using a Near-Infrared Spectroscopy (NIRS) device (INVOS™ oximeter) with sensors placed on the right and left frontal regions. The changes in s-rSO2 values will be recorded to evaluate the impact of manual versus AutoFlow mask ventilation during the induction of general anesthesia.
Time frame
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).Secondary outcomes
1
Change in Peripheral (Somatic) Regional Oxygen Saturation (p-rSO2)
Bilateral peripheral regional oxygen saturation will be measured using NIRS sensors placed on the volar surfaces of the right and left forearms to evaluate tissue oxygen delivery and peripheral perfusion.
Time frame
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).2
Mean Arterial Pressure (MAP)
Hemodynamic stability will be evaluated by recording Mean Arterial Pressure (MAP) using standard non-invasive monitor. Measurements will be tracked to ensure parameters remain within a ±20% margin of the baseline during induction.
Time frame
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).3
Peripheral Oxygen Saturation (SpO2)
Standard systemic oxygen saturation will be monitored non-invasively via pulse oximetry.
Time frame
Baseline prior to pre-oxygenation (T1), immediately after pre-oxygenation (T2), post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).4
End-Tidal Carbon Dioxide (EtCO2)
The efficacy of the mask ventilation techniques will be evaluated by recording End-Tidal Carbon Dioxide (EtCO2).
Time frame
Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).Sponsors and contacts
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Source ClinicalTrials.gov