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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Lung Cancer
• Intervention / Treatment: Device: High-flow Nasal Cannula Oxygen (HFNCO); Device: Conventional oxygen treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%.	Device: High-flow Nasal Cannula Oxygen (HFNCO)
Active Comparator: 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%.	Device: Conventional oxygen treatment

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: September 5, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HFNC after pulmonary lobectomy