- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07629102
Perioperative Respiratory Function in Sleeve Gastrectomy
Perioperative Oxygenation and Respiratory Function in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Retrospective Cohort Study
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Istanbul, Turecko (Türkiye)
- Basaksehir Cam and Sakura City Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: 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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Jiný: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PaO2/FiO2 ratio
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postoperative pulmonary function tests
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-134
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Studuje lékový produkt regulovaný americkým FDA
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