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

Primary Purpose

Respiratory Insufficiency, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High-flow Nasal Cannula Oxygen (HFNCO)
Conventional oxygen treatment
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-flow nasal cannula oxygen (HFNCO)

standard oxygen therapy

Arm Description

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%.

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%.

Outcomes

Primary Outcome Measures

Number of patients with hypoxemia (defined as a PaO2/FiO2 ratio <300) after pulmonary lobectomy in patients with lung cancer

Secondary Outcome Measures

Number of patients with SpO2 <93% in room air
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.
Postoperative pulmonary complications
Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort)

Full Information

First Posted
August 26, 2015
Last Updated
December 21, 2018
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT02544477
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-flow nasal cannula oxygen (HFNCO)
Arm Type
Experimental
Arm Description
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%.
Arm Title
standard oxygen therapy
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
High-flow Nasal Cannula Oxygen (HFNCO)
Intervention Type
Device
Intervention Name(s)
Conventional oxygen treatment
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Number of patients with SpO2 <93% in room air
Time Frame
after 48 hours from surgery and until 7th post operative day
Title
Number of patients undergoing endotracheal intubation or non-invasive ventilation for acute respiratory failure
Description
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.
Time Frame
during the first 7 days after surgery
Title
Postoperative pulmonary complications
Time Frame
during the first 7 days after surgery
Title
Respiratory discomfort evaluated by VAS (visual analogic scale) ranging from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Time Frame
during the first 96 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
30819227
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.
Results Reference
derived

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

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