High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High-flow nasal cannula oxygen (HFNCO)
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%.
Intervention: High-flow Nasal Cannula Oxygen (HFNCO) (Device)
standard oxygen therapy
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%.
Intervention: Conventional oxygen treatment (Device)
Outcomes
Primary Outcomes
Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer
Time Frame: during the first 96 hours after surgery
Secondary Outcomes
- Number of patients with SpO2 <93% in room air(after 48 hours from surgery and until 7th post operative day)
- 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)
- Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure(during the first 7 days after surgery)
Investigators
Maria Teresa Congedo
Medical Doctor
Catholic University of the Sacred Heart