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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544477
• Other study ID #: HFNC after pulmonary lobectomy
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• High-flow Nasal Cannula Oxygen (HFNCO)

• Conventional oxygen treatment

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with SpO2 <93% in room air		after 48 hours from surgery and until 7th post operative day
Secondary	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
Secondary	Postoperative pulmonary complications		during the first 7 days after surgery
Secondary	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