Lung Cancer, Respiratory Insufficiency
Conditions
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: 1. standard oxygen therapy group (control group) or 2. 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.
Interventions
DEVICEHigh-flow Nasal Cannula Oxygen (HFNCO)
DEVICEConventional oxygen treatment
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | during the first 7 days after surgery | 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. |
| 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 | — |
Countries
Italy
Outcome results
None listed