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Cerebral OxygenationNCT07582913

Manual Versus Autoflow Ventilation During Anesthesia Inductıon in Geriatric Patients

A study testing Manual Mask Ventilation and AutoFlow Mechanical Mask Ventilation in people with Cerebral Oxygenation and Peripheral Oxygenation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Manual Mask Ventilation and AutoFlow Mechanical Mask Ventilation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 May 2026to 5 Dec 2026
Phase
Interventional
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Patients with a known allergy to the monitoring sensor materials.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

FATMA G KILIÇASLAN, Resident contact

+905305692877

fatmagulgunkilicaslan@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

    Ankara, Çankaya, 06800

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Manual Versus Autoflow Ventilation During Anesthesia Induction on Cerebral and Peripheral Oxygenation in Geriatric Patients

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.

Read the detailed description

Ventilation strategies applied during the induction of general anesthesia have a significant impact on cerebral and peripheral oxygenation in geriatric patients. During the induction phase, respiratory and hemodynamic changes become more pronounced due to age-related physiological alterations such as diminished cardiopulmonary reserve, increased chest wall rigidity, decreased pulmonary elasticity, and impaired cerebral autoregulation. These changes increase the vulnerability of elderly patients to hypoxemia, hypocapnia, and imbalances in oxygen delivery. In particular, even brief episodes of hypoxemia or hypocapnia during induction may adversely affect cerebral oxygenation in this population.

Manual mask ventilation may result in unintentional hyperventilation or hypoventilation, potentially leading to hypocapnia and subsequent disturbances in cerebral oxygenation. In contrast, AutoFlow ventilation provides controlled ventilation with predefined parameters and may ensure more stable oxygen delivery.

This study is designed as a prospective, single-center, randomized controlled trial to compare the effects of manual ventilation and AutoFlow ventilation applied during the induction of general anesthesia on cerebral regional oxygen saturation (s-rSO₂) and peripheral (somatic) regional oxygen saturation (p-rSO₂) in geriatric patients. The primary hypothesis is that AutoFlow ventilation provides more stable cerebral and peripheral oxygenation compared to manual ventilation during the induction period.

The study will be conducted in the General and Oncology Operating Rooms of Ankara Bilkent City Hospital. Patients aged 65 years and older, of both sexes, classified as American Society of Anesthesiologists (ASA) physical status I-III, and scheduled for elective surgery requiring endotracheal intubation under general anesthesia will be included. A total of 106 patients (53 per group) will be enrolled based on power analysis, accounting for a potential 10% data loss.

Upon arrival in the operating room following standard preoperative fasting, demographic data (age, sex, height, weight, body mass index) and clinical characteristics (comorbidities, ASA classification) will be recorded. Standard ASA monitoring, including electrocardiography, non-invasive blood pressure, and pulse oximetry, will be applied. Cerebral and peripheral oxygenation will be continuously monitored using near-infrared spectroscopy (NIRS) with sensors placed bilaterally on the frontal region and on the volar surface of the forearms. Baseline values will be recorded before preoxygenation (T1).

Preoxygenation will be performed using 100% oxygen with a flow rate of 10 L/min until end-tidal oxygen (ETO₂) reaches 85% and plateaus for at least 30 seconds. Measurements at this stage will be recorded as T2.

Anesthesia induction will be standardized using fentanyl (1 µg/kg), lidocaine (1 mg/kg), propofol (2-3 mg/kg), and rocuronium (0.6-1 mg/kg), while maintaining hemodynamic stability within ±20% of baseline values. Following induction, mask ventilation with 100% oxygen will be applied for 2 minutes.

Patients will be randomly assigned using a computer-based block randomization method into two groups: manual ventilation and AutoFlow ventilation. In the manual ventilation group, ventilation will be performed by an experienced anesthesiologist or anesthesia resident using a reservoir bag. In the AutoFlow group, ventilation will be delivered by the anesthesia machine using predefined settings: tidal volume of 6 mL/kg (ideal body weight), respiratory rate of 12 breaths per minute, peak pressure limit of 30 cmH₂O, and positive end-expiratory pressure (PEEP) of 5 cmH₂O.

At the end of the 2-minute ventilation period before laryngoscopy, measurements will be recorded as T3 (post-induction, pre-intubation), including heart rate, mean arterial pressure, s-rSO₂, p-rSO₂, end-tidal carbon dioxide (EtCO₂), and peak inspiratory pressure (PIP). After endotracheal intubation and confirmation of tube placement, mechanical ventilation will be initiated and final measurements will be recorded as T4 (post-intubation).

To ensure standardization, NIRS device settings, including alarm limits, noise-reduction filters, and averaging time (8 seconds), will be kept constant for all patients. Factors that may affect measurements, such as motion artifacts, extremity temperature, arrhythmias, or vasopressor use, will be recorded.

Being tested
Manual Mask Ventilation, AutoFlow Mechanical Mask Ventilation
Keywords
Geriatrics, Near-Infrared Spectroscopy, Cerebral Oximetry, Cerebral Autoregulation, Mask Ventilation, Autoflow
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual Mask VentilationProcedure or surgery

    Patients 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 VentilationProcedure or surgery

    Patients 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

Study groups in NCT07582913
Study groupRoleWhat they receive
Group M (Manual Ventilation)Active comparatorFollowing the standardized induction of general anesthesia (1 µg/kg fentanyl, 1 mg/kg lidocaine, 2-3 mg/kg propofol, and 0.6-1 mg/kg rocuronium), mask ventilation with 100% oxygen will be manually performed by an experienced anesthesiologist or anesthesia resident. Manual ventilation using a reservoir bag will be maintained for 2 minutes to allow for adequate muscle relaxation prior to intubation.
Receives: Procedure: Manual Mask Ventilation
Group A (AutoFlow Ventilation)ExperimentalFollowing the same standardized general anesthesia induction protocol, mask ventilation with 100% oxygen will be mechanically delivered by the anesthesia workstation for 2 minutes. The device will be set to deliver a tidal volume (VT) of 6 mL/kg based on the patient's ideal body weight, a respiratory rate of 12 breaths/minute, a peak inspiratory pressure limit of 30 cmH₂O, and a Positive End-Expiratory Pressure (PEEP) of 5 cmH₂O.
Receives: Procedure: AutoFlow Mechanical Mask Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (7)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).

  5. Heart Rate

    Hemodynamic stability will be evaluated by recording Heart Rate (HR) using standard non-invasive monitor.

    Measured: 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).

  6. Peak Inspiratory Pressure (PIP)

    The efficacy of the mask ventilation techniques will be evaluated by recording Peak Inspiratory Pressure (PIP).

    Measured: Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).

  7. Tidal Volume (VT)

    The efficacy of the mask ventilation techniques will be evaluated by recording delivered Tidal Volume (VT).

    Measured: Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start13 May 2026
  3. Primary completion20 Oct 2026 (estimated)
  4. Study completion5 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07582913
Sponsor's protocol ID
TABED 1-26-2087
Status last verified
May 2026
First submitted
5 May 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burkhart CS, Rossi A, Dell-Kuster S, Gamberini M, Mockli A, Siegemund M, Czosnyka M, Strebel SP, Steiner LA. Effect of age on intraoperative cerebrovascular autoregulation and near-infrared spectroscopy-derived cerebral oxygenation. Br J Anaesth. 2011 Nov;107(5):742-8. doi: 10.1093/bja/aer252. Epub 2011 Aug 10.

    PubMed 21835838
  • Ishiyama T, Kotoda M, Asano N, Ikemoto K, Shintani N, Matsuoka T, Matsukawa T. Effects of hyperventilation on cerebral oxygen saturation estimated using near-infrared spectroscopy: A randomised comparison between propofol and sevoflurane anaesthesia. Eur J Anaesthesiol. 2016 Dec;33(12):929-935. doi: 10.1097/EJA.0000000000000507.

    PubMed 27802250
  • Groene P, Rapp M, Ninke T, Conzen P, Hofmann-Kiefer K. Impact of mild hypo- and hyperventilation on cerebral oxygen supply during general anesthesia. Perioper Med (Lond). 2025 Mar 17;14(1):30. doi: 10.1186/s13741-025-00517-9.

    PubMed 40091065

Questions about this trial

What is this clinical trial studying?

A study testing Manual Mask Ventilation and AutoFlow Mechanical Mask Ventilation in people with Cerebral Oxygenation and Peripheral Oxygenation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 May 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 Turkey (Türkiye). 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?

Contact FATMA G KILIÇASLAN, Resident (+905305692877, fatmagulgunkilicaslan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cerebral Regional Oxygen Saturation (s-rSO2) (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).). 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 NCT07582913, which also lists 3 linked publications.

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 15 May 2026.

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