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Effect on post-operative pulmonary complications frequency of high flow nasal oxygen versus standard oxygen therapy in patients undergoing esophagectomy for cancer: study protocol for a randomized controlled trial-OSSIGENA study.
Deana, Cristian; Vecchiato, Massimo; Azzolina, Danila; Turi, Stefano; Boscolo, Annalisa; Pistollato, Elisa; Skurzak, Stefano; Amici, Ombretta; Priolo, Simone; Tonini, Simone; Foti, Lorenzo Santo; Taddei, Erika; Aceto, Paola; Martino, Antonio; Ziccarelli, Antonio; Cereser, Lorenzo; Andreutti, Simonetta; De Carlo, Stefano; Lirussi, Kevin; Barbariol, Federico; Cammarota, Gianmaria; Polati, Enrico; Forfori, Francesco; Corradi, Francesco; Patruno, Vincenzo; Navalesi, Paolo; Maggiore, Salvatore Maurizio; Lucchese, Francesca; Petri, Roberto; Bassi, Flavio; Romagnoli, Stefano; Bignami, Elena Giovanna; Vetrugno, Luigi.
Afiliação
  • Deana C; Anesthesia and Intensive Care 1, Department of Anesthesia and Intensive Care, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Vecchiato M; General Surgery Unit, Department of Surgery, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Azzolina D; Department of Preventive and Environmental Science, University of Ferrara, Ferrara, Italy.
  • Turi S; Clinical Trial and Biostatistics, Research and Development Unit, University Hospital of Ferrara, Ferrara, Italy.
  • Boscolo A; Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Pistollato E; Department of Medicine, University of Padua, Padua, Italy.
  • Skurzak S; Anesthesia and Intensive Care Unit, Padua University Hospital, Padua, Italy.
  • Amici O; Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padova, Padua, Italy.
  • Priolo S; Department of Medicine, University of Padua, Padua, Italy.
  • Tonini S; Section of Anesthesia and Intensive Care, Città della Salute e della Scienza, Turin, Italy.
  • Foti LS; Department of Anesthesia, ASST GOM Niguarda, Milan, Italy.
  • Taddei E; Intensive Care and Anesthesia Unit, Azienda Ospedaliera Universitaria Integrata (AOUI) Verona, Verona, Italy.
  • Aceto P; Emergency Department, GB Morgagni-Pierantoni Hospital, Forlì, Italy.
  • Martino A; Department of Anesthesia and Critical Care, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
  • Ziccarelli A; Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.
  • Cereser L; Department of Emergency, Anesthesiologic and Reanimation Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
  • Andreutti S; Department of Basic Biotechnological Science, Intensive and Peri-Operative Clinics, Catholic University of the Sacred Heart, Rome, Italy.
  • De Carlo S; General Surgery Unit, Department of Surgery, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Lirussi K; General Surgery Unit, Department of Surgery, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Barbariol F; Institute of Radiology, Department of Medicine, University of Udine, University Hospital "S. Maria della Misericordia", Udine, Italy.
  • Cammarota G; Anesthesia and Intensive Care 1, Department of Anesthesia and Intensive Care, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Polati E; Anesthesia and Intensive Care 1, Department of Anesthesia and Intensive Care, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Forfori F; Anesthesia and Intensive Care 1, Department of Anesthesia and Intensive Care, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Corradi F; Anesthesia and Intensive Care 1, Department of Anesthesia and Intensive Care, Health Integrated Agency of Friuli Centrale, Udine, Italy.
  • Patruno V; Department of Translational Medicine, Università del Piemonte Orientale, Novara, Italy.
  • Navalesi P; Intensive Care and Anesthesia Unit, Azienda Ospedaliera Universitaria Integrata (AOUI) Verona, Verona, Italy.
  • Maggiore SM; Anesthesiology, Intensive Care and Pain Therapy Center, Department of Surgery, University of Verona, Verona, Italy.
  • Lucchese F; Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.
  • Petri R; Department of Surgical, Medical, Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.
  • Bassi F; Department of Pulmonology, S. Maria della Misericordia University Hospital, Udine, Italy.
  • Romagnoli S; Department of Medicine, University of Padua, Padua, Italy.
  • Bignami EG; Anesthesia and Intensive Care Unit, Padua University Hospital, Padua, Italy.
  • Vetrugno L; Department of Anesthesiology, Critical Care Medicine and Emergency, SS. Annunziata Hospital, Chieti, Italy.
J Thorac Dis ; 16(8): 5388-5398, 2024 Aug 31.
Article em En | MEDLINE | ID: mdl-39268119
ABSTRACT

Background:

Postoperative pulmonary complications (PPCs) remain a challenge after esophagectomy. Despite improvement in surgical and anesthesiological management, PPCs are reported in as many as 40% of patients. The main aim of this study is to investigate whether early application of high-flow nasal cannula (HFNC) after extubation will provide benefit in terms of reduced PPC frequency compared to standard oxygen therapy.

Methods:

Patients aged 18-85 years undergoing esophagectomy for cancer treatment with radical intent, excluding those with American Society of Anesthesiologists (ASA) score >3 and severe systemic comorbidity (cardiac, pulmonary, renal or hepatic disease) will be randomized at the end of surgery to receive HFNC or standard oxygen therapy (Venturi mask or nasal goggles) after early extubation (within 12 hours after the end of surgery) for 48 hours. The main postoperative goals are to obtain SpO2 ≥94% and adequate pain control. Oxygen therapy after 48 hours will be stopped unless the physician deems it necessary. In case of respiratory clinical worsening, patients will be supported with the most appropriate tool (noninvasive ventilation or invasive mechanical ventilation). Pulmonary [pneumonia, pleural effusion, pneumothorax, atelectasis, acute respiratory distress syndrome (ARDS), tracheo-bronchial injury, air leak, reintubation, and/or respiratory failure] complications will be recorded as main outcome. Secondary outcomes, including cardiovascular, surgical, renal and infective complications will also be recorded. The primary analysis will be carried out on 320 patients (160 per group) and performed on an intention-to-treat (ITT) basis, including all participants randomized into the treatment groups, regardless of protocol adherence. The primary outcome, the PPC rate, will be compared between the two treatment groups using a chi-square test for categorical data, or Fisher's exact test will be used if the assumptions for the chi-square test are not met.

Discussion:

Recent evidence demonstrated that early application of HFNC improved the respiratory rate oxygenation index (ROX index) after esophagectomy but did not reduce PPCs. This randomized controlled multicenter trial aims to assess the potential effect of the application of HFNC versus standard oxygen over PPCs in patients undergoing esophagectomy. Trial Registration This study is registered at clinicaltrial.gov NCT05718284, dated 30 January 2023.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: J Thorac Dis Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Itália País de publicação: China

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: J Thorac Dis Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Itália País de publicação: China