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Manual Versus Autoflow Ventilation During Anesthesia Inductıon in Geriatric Patients

13. Mai 2026 aktualisiert von: Fatma GÜLGÜN KILIÇASLAN, Ankara City Hospital Bilkent

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

106

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Çankaya
      • Ankara, Çankaya, Türkei (türkiye), 06800
        • Rekrutierung
        • Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Group M (Manual Ventilation)
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.
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.
Experimental: Group A (AutoFlow Ventilation)
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.
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Cerebral Regional Oxygen Saturation (s-rSO2)
Zeitfenster: 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).
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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Peripheral (Somatic) Regional Oxygen Saturation (p-rSO2)
Zeitfenster: 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).
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.
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)
Zeitfenster: 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).
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.
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)
Zeitfenster: 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).
Standard systemic oxygen saturation will be monitored non-invasively via pulse oximetry.
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)
Zeitfenster: Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
The efficacy of the mask ventilation techniques will be evaluated by recording End-Tidal Carbon Dioxide (EtCO2).
Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Heart Rate
Zeitfenster: 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).
Hemodynamic stability will be evaluated by recording Heart Rate (HR) using standard non-invasive monitor.
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).
Peak Inspiratory Pressure (PIP)
Zeitfenster: Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
The efficacy of the mask ventilation techniques will be evaluated by recording Peak Inspiratory Pressure (PIP).
Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
Tidal Volume (VT)
Zeitfenster: Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).
The efficacy of the mask ventilation techniques will be evaluated by recording delivered Tidal Volume (VT).
Post-induction/pre-intubation following 2 minutes of mask ventilation (T3), and immediately post-intubation (T4).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienleiter: EYÜP HORASANLI, Professor, Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Mai 2026

Primärer Abschluss (Geschätzt)

20. Oktober 2026

Studienabschluss (Geschätzt)

5. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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