Flow-Controlled vs Volume-Controlled Ventilation in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ankara, Turquie (Türkiye), 06230
- Ankara Education and Research Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
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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.
Autres noms:
|
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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.
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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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intraoperative Respiratory Mechanics
Délai: From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively
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Comparison of driving pressure between FCV and VCV groups at defined intraoperative time points.
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From intubation to end of surgery, measured after intubation, after insufflation, and at 30-minute intervals intraoperatively
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Mean Arterial Pressure
Délai: From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery
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Comparison of mean arterial pressure (MAP) between FCV and VCV groups at defined intraoperative time points.
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From preoperative baseline to end of surgery, measured before surgery, after intubation, after insufflation, at 30-minute intervals intraoperatively, and at end of surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pa02/Fi02 ratio
Délai: From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery.
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Comparison of Horowitz index between FCV and VCV groups.
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From intubation to end of surgery, measured after intubation, after insufflation, at 30-minute intervals intraoperatively and at the end of the surgery.
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Postoperative Oxygen Theraphy Need
Délai: Within 24 hours after surgery
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Comparison of percentage of participants requiring postoperative oxygen therapy requirement between FCV and VCV groups.
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Within 24 hours after surgery
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Postoperative Intensive Unit Admission
Délai: Within 24 hours after surgery
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Comparison of the number of patients requiring admission to the intensive care unit between the FCV and VCV groups.
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Within 24 hours after surgery
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Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Délai: 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
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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.
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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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- E-25-418
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
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