Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Flow-Controlled vs Volume-Controlled Ventilation in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

7. Juni 2026 aktualisiert von: MD, Tugce Ozdogan, Ankara Training and Research Hospital

Investigation of the Effects of Flow-Controlled Ventilation and Volume-Controlled Ventilation on Pulmonary Dynamics and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

The goal of this clinical trial is to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on hemodynamic and respiratory parameters in obese patients undergoing elective laparoscopic bariatric surgery. The main questions it aims to answer are:

Does FCV provide better intraoperative hemodynamic and respiratory stability compared to VCV during laparoscopic bariatric surgery? Is FCV a safe and feasible ventilation strategy under high intraabdominal pressure and position changes required in bariatric surgery?

Researchers will compare FCV group to VCV group to see if FCV improves intraoperative respiratory mechanics and hemodynamic parameters.

Participants will:

Undergo elective laparoscopic bariatric surgery with BMI >40 kg/m² (ASA I-III) Receive either flow-controlled or volume-controlled ventilation with individualized PEEP and tidal volume of 6-8 ml/kg predicted body weight Have intraoperative hemodynamic and respiratory parameters monitored at regular intervals, including arterial blood gas analysis Be followed postoperatively for oxygen therapy requirement and intensive care need

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Laparoscopic surgery is associated with significant physiological changes due to pneumoperitoneum, which adversely affects hemodynamic and respiratory parameters, thereby complicating intraoperative anesthetic management. These challenges are particularly pronounced in obese patients, who present with reduced functional residual capacity and other physiological alterations that impact both intraoperative and postoperative outcomes.

Although bariatric surgery has conventionally been managed with volume-controlled ventilation (VCV), recent studies have highlighted the potential benefits of flow-controlled ventilation (FCV) in terms of safety and contribution to lung-protective ventilation strategies.

This study primarily aims to compare the effects of FCV and VCV on intraoperative hemodynamic and respiratory function dynamics in patients undergoing bariatric surgery. Secondarily, the study evaluates the clinical feasibility and safety of FCV under the high intraabdominal pressures and position changes required during bariatric procedures.

Study Design:

This study includes 34 patients with BMI >40 kg/m² classified as ASA I-III scheduled for elective laparoscopic bariatric surgery. Seventeen patients were prospectively managed with FCV, while data from 17 patients managed with VCV were retrospectively reviewed. All patients received standard monitoring plus intra-arterial blood pressure monitoring. Anesthesia induction and maintenance protocols were identical across both groups.

Ventilation Protocol:

In the FCV group, a tidal volume (VT) of 6-8 ml/kg predicted body weight was targeted, and positive end-expiratory pressure (PEEP) was individualized based on compliance following CO₂ insufflation. The same tidal volume strategy was applied in the VCV group with PEEP titration performed in eligible patients.

Measurements:

The following parameters were recorded after intubation, after insufflation, and at 30-minute intervals intraoperatively: mean arterial pressure (MAP), heart rate, peripheral oxygen saturation (SpO₂), plateau airway pressure (Pplat), peak airway pressure (Ppeak), driving pressure, end-tidal CO₂ (EtCO₂), minute volume, respiratory rate (RR), airway resistance (Raw), and static compliance (Cstatic) calculated as VT/(Pplat-PEEP). Arterial blood gas parameters including pH, PaCO₂, PaO₂, SaO₂, hemoglobin, and lactate were also recorded. Postoperative oxygen therapy requirement and intensive care unit admission were monitored.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

34

Kontakte und Standorte

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

Studienkontakt

Studienorte

  • Türkei (türkiye)
      • Ankara, Türkei (türkiye), 06230
        • Rekrutierung
        • Ankara Education and Research Hospital
        • Kontakt:
        • Unterermittler:
          • Asutay Goktug, MD,PhD
        • Unterermittler:
          • Hülya Basar, MD,Phd
        • Unterermittler:
          • Mustafa Kaan Bozkurt, MD
        • Unterermittler:
          • Cetin Kaymak, MD, PhD

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

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult morbidly obese patients (BMI ≥40 kg/m²) aged 18-65 years, classified as ASA I-III, scheduled for elective laparoscopic bariatric surgery at Ankara Training and Research Hospital.

Beschreibung

Inclusion Criteria:

  • Age between 18 and 65 years American Society of Anesthesiologists (ASA) physical status I, II, or III Body Mass Index (BMI) ≥ 40 kg/m² Scheduled for elective laparoscopic bariatric surgery Willing to participate in the study

Exclusion Criteria:

  • ASA physical status IV or V Emergency surgical procedures Pregnant patients Patients requiring vasopressor support to maintain mean arterial pressure above 65 mmHg intraoperatively Patients with advanced pulmonary disease Patients who decline to participate in the study

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
FCV Group
Patients undergoing elective laparoscopic bariatric surgery managed with flow-controlled ventilation (FCV) with tidal volume of 6-8 ml/kg predicted body weight and individualized PEEP based on compliance following CO₂ insufflation.
Gerät: Flow-Controlled Ventilation (FCV)
Patients were ventilated using flow-controlled ventilation with a tidal volume of 6-8 ml/kg predicted body weight. PEEP was individualized based on respiratory compliance following CO₂ insufflation.
Andere Namen:
  • FCV
VCV Group
Patients undergoing elective laparoscopic bariatric surgery managed with volume-controlled ventilation (VCV) with tidal volume of 6-8 ml/kg predicted body weight and PEEP titration performed in eligible patients. Data collected retrospectively.
Gerät: Volume-Controlled Ventilation (VCV)
Patients were ventilated using volume-controlled ventilation with a tidal volume of 6-8 ml/kg predicted body weight. PEEP titration was performed in eligible patients.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intraoperative Respiratory Mechanics
Zeitfenster: From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively
Comparison of driving pressure between FCV and VCV groups at defined intraoperative time points.
From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively
Mean Arterial Pressure
Zeitfenster: From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery
Comparison of mean arterial pressure (MAP) between FCV and VCV groups at defined intraoperative time points.
From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pa02/Fi02 ratio
Zeitfenster: From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery.
Comparison of Horowitz index between FCV and VCV groups.
From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery.
Postoperative Oxygen Theraphy Need
Zeitfenster: Within 24 hours after surgery
Comparison of percentage of participants requiring postoperative oxygen therapy requirement between FCV and VCV groups.
Within 24 hours after surgery
Postoperative Intensive Unit Admission
Zeitfenster: Within 24 hours after surgery
Comparison of the number of patients requiring admission to the intensive care unit between the FCV and VCV groups.
Within 24 hours after surgery
Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Zeitfenster: From intubation to the end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively and at the end of the operation
Comparison of arterial partial pressure of carbon dioxide (PaCO2) between the FCV and VCV groups to evaluate efficiency of carbon dioxide elimination at defined time points.
From intubation to the end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively and at the end of the operation

Mitarbeiter und Ermittler

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

Sponsor

Ankara Training and Research Hospital

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)

15. März 2026

Primärer Abschluss (Geschätzt)

1. August 2026

Studienabschluss (Geschätzt)

1. August 2026

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • E-25-418

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data will be shared upon reasonable request.

IPD-Sharing-Zeitrahmen

Beginning 6 months after publication and ending 5 years following article publication

IPD-Sharing-Zugriffskriterien

Individual participant data will be available upon reasonable request to the corresponding author.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

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 .

Klinische Studien zur Fettleibigkeit, krankhaft

Klinische Studien zur Flow-Controlled Ventilation (FCV)

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Kosovo

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren