- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03157479
Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery (Inprove4large)
Intraoperative Protective Ventilation for Obese Patients Undergoing Gynaecological Laparoscopic Surgery. A Single-centre Randomized, Controlled Trial
Background. The use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. It is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and Trendelenburg position may alter lung volumes and chest-wall elastance.
Objective. The investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Rome, Włochy, 00100
- General surgery OR, A. Gemelli hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- scheduled for gynaecological laparoscopic surgery in the Trendelenburg position
- Obesity with body mass index>35 kg/m^2
- written informed consent
Exclusion Criteria:
- Clinical history or signs of chronic heart failure
- history of neuromuscular disease
- history of thoracic surgery
- pregnancy
- chronic respiratory failure requiring long-term oxygen administration
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Protective ventilation
Volume controlled ventilation with tidal volume 6-7 ml/kg of predicted body weight (45.5 + 0.91 (height [cm] -152.4)),
FiO2 0.4 and PEEP 10 cmH2O during the whole study period.
Respiratory rate will be titrated to keep end-tidal CO2 values between 30 and 40 mmHg.
I:E ratio will be set in order to obtain an inspiratory time of 0.8 seconds and an inspiratory pause of 0.3 seconds and FiO2 will be kept unchanged during the whole study period.
In patients in this group, recruiting maneuvers will be performed throughout a stepwise 5 cmH2O PEEP increase every 30 seconds to achieve a PEEP of 35 cmH2O during Pressure Controlled Ventilation (10 cmH2O of inspiratory pressure while keeping respiratory rate unmodified), followed by a stepwise 5 cmH2O PEEP reduction every 30 seconds until the baseline set peep is reached.
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Anaesthesia induction will be obtained with i.v.
2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium.
Anaesthesia will be maintained with i.v.
propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h.
Treatment of eventual hemodynamic instability will be left to the attending physician
A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.
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Aktywny komparator: Standard Ventilation
Volume controlled ventilation with tidal volume 10 ml/kg of PBW (45.5 + 0.91 (height [cm] -152.4)),
FiO2 0.4 and PEEP 5 cmH2O during the whole study period.
Respiratory rate will be titrated to keep end-tidal CO2 values between 30 mmHg and 40 mmHg.
I:E ratio will be set in order to obtain an inspiratory time of 0.8-1 seconds and an inspiratory pause of 0.3 second
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Anaesthesia induction will be obtained with i.v.
2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium.
Anaesthesia will be maintained with i.v.
propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h.
Treatment of eventual hemodynamic instability will be left to the attending physician
A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Postoperative oxygenation
Ramy czasowe: One hour after extubation
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PaO2/FiO2 ratio 1 hour after extubation, while the patient is receiving oxygen through VenturiMask 40%
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One hour after extubation
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Postoperative forced expiratory volume in 1 second (FEV1)
Ramy czasowe: 48 hours after the end of surgery
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volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity
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48 hours after the end of surgery
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Postoperative forced vital capacity (FVC)
Ramy czasowe: 48 hours after the end of surgery
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the total amount of air exhaled during a forced expiratory maneuver started from the level of total lung capacity
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48 hours after the end of surgery
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Postoperative Tiffeneau index
Ramy czasowe: 48 hours after the end of surgery
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computed as FEV1/FVC
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48 hours after the end of surgery
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Postoperative Dyspnea
Ramy czasowe: 1 hour after surgery
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Dyspnea assessed by Borg dyspnea scale
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1 hour after surgery
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Pulmonary infection
Ramy czasowe: 24 hours after the end of surgery
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modified clinical pulmonary infection score (mCPIS)
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24 hours after the end of surgery
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Postoperative pulmonary infiltrates
Ramy czasowe: 24 hours after the end of surgery
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Evaluated with the chest x-ray by two independent clinicians blinded to treatment assignment
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24 hours after the end of surgery
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Intraoperative driving pressure
Ramy czasowe: during surgery, recorded on a 60-minute basis
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driving pressure, computed as Plateau pressure-PEEP
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during surgery, recorded on a 60-minute basis
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Intraoperative lung driving pressure
Ramy czasowe: during surgery, recorded on a 60-minute basis
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transpulmonary driving pressure, computed as Transpulmonary end-inspiratory pressure-transpulmonary total end-expiratory pressure
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during surgery, recorded on a 60-minute basis
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Intraoperative oxygenation
Ramy czasowe: during surgery, recorded on a 60-minute basis
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PaO2/FiO2
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during surgery, recorded on a 60-minute basis
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Intraoperative dead space
Ramy czasowe: during surgery, recorded on a 60-minute basis
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Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2
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during surgery, recorded on a 60-minute basis
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Lung recruitment
Ramy czasowe: during surgery, recorded on a 60-minute basis
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lung recruitment/changes in end expiratory lung volume between the two groups
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during surgery, recorded on a 60-minute basis
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Intraoperative blood pressure
Ramy czasowe: during surgery, recorded on a 60-minute basis
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Arterial blood pressure
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during surgery, recorded on a 60-minute basis
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Intraoperative respiratory system compliance
Ramy czasowe: during surgery, recorded on a 60-minute basis
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computed as Tidal volume/airway driving pressure
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during surgery, recorded on a 60-minute basis
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Intraoperative lung compliance
Ramy czasowe: during surgery, recorded on a 60-minute basis
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computed as Tidal volume/lung driving pressure
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during surgery, recorded on a 60-minute basis
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- InproveForLarge
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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