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- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Rome, Italie, 00100
- General surgery OR, A. Gemelli hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Postoperative oxygenation
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Postoperative forced expiratory volume in 1 second (FEV1)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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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
- InproveForLarge
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Informations sur les médicaments et les dispositifs, documents d'étude
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