High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy

Study Overview
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Brief Summary
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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

Detailed Description
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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: standard oxygen therapy group (control group) or HFNCO group (study group). 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.

Official Title
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High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy

Conditions
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Respiratory Insufficiency, Lung Cancer

Intervention / Treatment
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* Device: High-flow Nasal Cannula Oxygen (HFNCO)
* Device: Conventional oxygen treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned pulmonary lobectomy for lung cancer Exclusion Criteria: age <18 years patient refusal body mass index ≥35 kg/m2 sleep apnea syndrome tracheostomy home oxygen therapy pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flow nasal cannula oxygen (HFNCO)<br>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%. | Device: High-flow Nasal Cannula Oxygen (HFNCO)<br> <br> |
| Active Comparator: standard oxygen therapy<br>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%. | Device: Conventional oxygen treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 acidosis (arterial pH ≤7.35 with PaCO2 ≥ 45 mm Hg); SpO2 < 90% or PaO2 < 60 mmHg at an FiO2 ≥ 0.5; respiratory frequency > 35/min; altered state of consciousness; clinical signs of respiratory muscle fatigue. 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: respiratory or cardiac arrest; respiratory pauses with loss of consciousness or gasping; psychomotor agitation inadequately controlled by sedation; massive aspiration; persistent inability to remove respiratory secretions; heart rate < 50/min with loss of alertness; severe hemodynamic instability without response to fluids and vasoactive drugs. Patients with deterioration of blood gases or tachypnea despite 1 hour of NIV will undergo ETI. | 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 |