Clinical trial NCT02544477: High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
Official title: High-flow Nasal Cannula Oxygen Versus Conventional Oxygen Therapy After Pulmonary Lobectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Lung Cancer
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer
timeFrame: during the first 96 hours after surgery
Secondary outcomes:
measure: Number of patients with SpO2 <93% in room air
timeFrame: after 48 hours from surgery and until 7th post operative day
measure: Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure
timeFrame: during the first 7 days after surgery
measure: Postoperative pulmonary complications
timeFrame: during the first 7 days after surgery
measure: Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort)
timeFrame: during the first 96 hours after surgery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
References:
citation: 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.