- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07629102
Perioperative Respiratory Function in Sleeve Gastrectomy
Perioperative Oxygenation and Respiratory Function in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Obesity is associated with substantial alterations in respiratory physiology, including reduced functional residual capacity, decreased respiratory compliance, impaired diaphragmatic excursion, and increased susceptibility to perioperative atelectasis and hypoxemia. These physiologic changes become more pronounced during general anesthesia and laparoscopic surgery because of positive-pressure ventilation and carbon dioxide pneumoperitoneum. Consequently, obese patients undergoing bariatric surgery represent a particularly vulnerable population for perioperative respiratory impairment.
Lung-protective ventilation strategies incorporating low tidal volume ventilation, positive end-expiratory pressure (PEEP), and recruitment maneuvers have been increasingly utilized in obese surgical patients to improve oxygenation and reduce atelectatic changes. However, despite improvements in intraoperative respiratory mechanics and oxygenation reported in previous studies, the clinical significance and incremental benefit of intensified ventilation strategies remain uncertain, particularly in contemporary bariatric anesthesia settings where protective ventilation principles are already routinely applied.
This retrospective single-center cohort study evaluates perioperative oxygenation and respiratory outcomes in obese patients undergoing elective laparoscopic sleeve gastrectomy between January 2021 and January 2026. All patients were managed using standardized anesthetic and surgical protocols, including volume-controlled ventilation with tidal volumes of 6-8 mL/kg ideal body weight and fixed inspired oxygen fraction (FiO₂ 45%).
Patients were divided into two groups according to intraoperative ventilation strategy. The first group received conventional ventilation with PEEP 5 cmH₂O without recruitment maneuvers. The second group received a protective ventilation strategy consisting of PEEP 8 cmH₂O combined with repeated recruitment maneuvers performed after pneumoperitoneum establishment and before extubation.
Perioperative oxygenation was assessed using serial PaO₂/FiO₂ measurements obtained immediately after endotracheal intubation (T0), 10 minutes after pneumoperitoneum establishment (T1), and 5 minutes after extubation (T2). Secondary outcomes included arterial blood gas variables, postoperative spirometric parameters, lactate levels, intensive care unit admission, and hospital length of stay.
The primary objective of the study is to determine whether escalation from conventional PEEP 5 cmH₂O ventilation to PEEP 8 cmH₂O combined with recruitment maneuvers provides incremental perioperative respiratory benefit in obese patients undergoing laparoscopic sleeve gastrectomy within a standardized contemporary bariatric anesthesia setting.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Başakşehir Çam and Sakura City Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-III who underwent elective laparoscopic sleeve gastrectomy
Exclusion Criteria:
- revision bariatric surgery
- gastric bypass surgery
- conversion to open surgery
- incomplete perioperative records
- missing arterial blood gas measurements
- unavailable postoperative pulmonary function tests
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: PEEP 5/no recruitment maneuver
Patients were ventilated with a positive end-expiratory pressure (PEEP) of 5 cmH₂O without recruitment maneuvers
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Patients were ventilated with a positive end-expiratory pressure (PEEP) of 5 cmH₂O without recruitment maneuvers
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Otro: PEEP 8/recruitment maneuver
Patients received a protective ventilation strategy consisting of PEEP 8 cmH₂O combined with repeated recruitment maneuvers performed after pneumoperitoneum insufflation and before extubation
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Recruitment maneuvers were performed using a stepwise PEEP increase strategy.
PEEP levels were gradually increased over consecutive respiratory cycles up to 15-20 cmH₂O and subsequently reduced to the assigned maintenance PEEP level.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PaO2/FiO2 ratio
Periodo de tiempo: T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
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The primary outcome of the study was perioperative oxygenation assessed by serial PaO2/FiO2 ratio measurements.
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T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative pulmonary function tests
Periodo de tiempo: Were evaluated before the surgery and on the day of hospital discharge
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forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio
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Were evaluated before the surgery and on the day of hospital discharge
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Intensive care unit admission
Periodo de tiempo: Postoperative day 0
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Patients requiring intensive care admission
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Postoperative day 0
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PaCO₂, pH, oxygen saturation
Periodo de tiempo: T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
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Blood gas analyses parameters
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T0: immediately after endotracheal intubation • T1: 10 minutes after establishment of pneumoperitoneum and achievement of the target intra-abdominal pressure • T2: 5 minutes afte
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Hospital length of stay
Periodo de tiempo: On which day the patients were discharged
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How many days did the patient stay in the hospital?
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On which day the patients were discharged
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-134
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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