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The primary objective of this study is to evaluate the effect of early application of nasal high flow oxygen therapy after pulmonary lobectomy on the incidence of postoperative hypoxemia
High-flow nasal cannula oxygen (HFNCO) treatment has been showed to have several clinical advantages compared with conventional oxygen therapy. Currently, no reports have described the effects of HFNCO in postoperative patients after thoracic surgery. The primary objective of this study is to determine the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) in patients with lung cancer after pulmonary lobectomy.
In the postoperative period after extubation, patients will be randomly assigned to either:
In the control group, patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. Patients in the study group will be given HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) = 92% - 98%. After 48 hours from study entry, all patients will be evaluated for possible interruption of oxygen treatment on the basis of their clinical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow nasal cannula oxygen (HFNCO) | Experimental | Patients will receive HFNCO treatment with a gas flow level = 50 L/min and a FiO2 set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%. |
|
| standard oxygen therapy | Active Comparator | Patients will receive oxygen treatment by means of a conventional face mask, with a level of fraction of inspired oxygen (FiO2) set to maintain peripheral oxygen saturation (SpO2) of 92% - 98%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow Nasal Cannula Oxygen (HFNCO) | Device |
| ||
| Conventional oxygen treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer | during the first 96 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with SpO2 <93% in room air | after 48 hours from surgery and until 7th post operative day | |
| Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure | Respiratory failure will be defined as the presence of at least two of the following:
Respiratory failure will be treated using noninvasive ventilation (NIV), except when endotracheal intubation (ETI) will be required, i.e., when any of the following clinical events will be present:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30819227 | Derived | Pennisi MA, Bello G, Congedo MT, Montini L, Nachira D, Ferretti GM, Meacci E, Gualtieri E, De Pascale G, Grieco DL, Margaritora S, Antonelli M. Early nasal high-flow versus Venturi mask oxygen therapy after lung resection: a randomized trial. Crit Care. 2019 Feb 28;23(1):68. doi: 10.1186/s13054-019-2361-5. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| Device |
|
| during the first 7 days after surgery |
| Postoperative pulmonary complications | during the first 7 days after surgery |
| Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort) | during the first 96 hours after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |