Manual Versus Autoflow Ventilation During Anesthesia Inductıon in Geriatric Patients

NCT07582913 | Recruiting

• 1 other identifier: TABED 1-26-2087
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Oxygenation; Geriatrics; Peripheral Oxygenation; Ventilation; Near-Infrared Spectroscopy

Keywords

Geriatrics; Near-Infrared Spectroscopy; Cerebral Oximetry; Cerebral Autoregulation; Mask Ventilation; Autoflow

Outcome Measures

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.

  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)

• Change in Peripheral (Somatic) Regional Oxygen Saturation (p-rSO2)

  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).

• Mean Arterial Pressure (MAP)

  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).

• Peripheral Oxygen Saturation (SpO2)

  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).

• End-Tidal Carbon Dioxide (EtCO2)

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

• Heart Rate

  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).

Study Arms (2)

Group M (Manual Ventilation)

ACTIVE COMPARATOR

Following 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.

Procedure: Manual Mask Ventilation

Group A (AutoFlow Ventilation)

EXPERIMENTAL

Following 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.

Procedure: AutoFlow Mechanical Mask Ventilation

Interventions

Manual Mask Ventilation PROCEDURE

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.

Group M (Manual Ventilation)

AutoFlow Mechanical Mask Ventilation PROCEDURE

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

Group A (AutoFlow Ventilation)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 21835838 BACKGROUND

• 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.

  PMID: 27802250 BACKGROUND

• 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.

  PMID: 40091065 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• EYÜP HORASANLI, Professor

  Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Central Study Contacts

FATMA G KILIÇASLAN, Resident

CONTACT

+905305692877; fatmagulgunkilicaslan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 13, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)