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

7. juni 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

34

Kontakter og lokationer

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Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06230
        • Rekruttering
        • Ankara Education and Research Hospital
        • Kontakt:
        • Underforsker:
          • Asutay Goktug, MD,PhD
        • Underforsker:
          • Hülya Basar, MD,Phd
        • Underforsker:
          • Mustafa Kaan Bozkurt, MD
        • Underforsker:
          • Cetin Kaymak, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: 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.
Andre navne:
  • 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative Respiratory Mechanics
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pa02/Fi02 ratio
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ankara Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. marts 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E-25-418

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data will be shared upon reasonable request.

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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Kliniske forsøg med Fedme, sygelig

Kliniske forsøg med Flow-Controlled Ventilation (FCV)

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