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Comparison of HFNC With NIV in Weaning COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High flow nasal cannula
Noninvasive ventilation
Sponsored by
Jie Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation focused on measuring Weaning; Noninvasive ventilation; High flow nasal cannula

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intubated patients with Chronic obstructive pulmonary disease exacerbation
  • Meeting extubation criteria (Pulmonary infection control window)
  • Age > 21years and < 90 years

Exclusion Criteria:

  • Tracheotomy
  • Combined with severe dysfunction of other organs, including heart, brain, liver, and renal failure;
  • Hemodynamic instability
  • Contraindication to NIV: cannot use mask, such as facial injury, burns or deformities; cannot cooperate with NIV such as delirium; copious secretions with weak cough ability; gastric over distention, and vomiting;
  • Contraindication to HFNC: rhinitis, nasal congestion, deformities or blockage.
  • Weak cough ability with copious secretions
  • Refuse to participate in the study

Sites / Locations

  • Binzhou Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow nasal cannula

Noninvasive ventilation

Arm Description

High flow nasal cannula (HFNC) is a type of oxygen device, which provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation.

Non-invasive ventilation (NIV) refers to the provision of ventilatory support through the patient's upper airway using a mask. This technique is distinguished from those which bypass the upper airway with a tracheal tube, laryngeal mask, or tracheostomy and are therefore considered invasive.

Outcomes

Primary Outcome Measures

pH
pH
PaCO2
PaCO2 in mmHg
PaO2/FiO2
partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg
HR
Heart Rate in beats per minute
MAP
mean arterial pressure in mmHg
RR
respiratory rate in breaths per minute

Secondary Outcome Measures

duration of respiratory support
hours of ventilator use
Length of ICU stay
Days of stay in ICU
Mortality
the patients' comfort score
comfort score of using high flow nasal cannula or noninvasive ventilator, ranging from 1 to 10. 1 means very comfortable, 10 means very uncomfortable.
incidence of nasal trauma
incidence of barotrauma

Full Information

First Posted
March 2, 2018
Last Updated
August 20, 2018
Sponsor
Jie Li
Collaborators
Binzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03458364
Brief Title
Comparison of HFNC With NIV in Weaning COPD
Official Title
Comparison of High Flow Nasal Cannula With Noninvasive Ventilation in Facilitating Weaning Chronic Obstructive Pulmonary Disease From Invasive Ventilation: a Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jie Li
Collaborators
Binzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
High flow nasal cannula (HFNC) has been shown to improve oxygenation and facilitate weaning in hypoxemia patients. Some clinical studies show the benefits of using HFNC in COPD patients, including reducing dead space and work of breathing. However, no clinical study has been to investigate the value of HFNC in weaning COPD patients from invasive ventilation. Thus, we proposed a randomized controlled trial to compare the use of HFNC and noninvasive ventilation (NIV) in weaning COPD.
Detailed Description
High flow nasal cannula (HFNC) provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation. In a recent meta-analysis of seven trials with 1771 patients, HFNC was shown to improve oxygenation and avoid intubation in patients with severe hypoxemia. The high velocity of the gas can rinse the dead space of the upper airway and reduce CO2 rebreathing, reduce COPD patients' work of breathing and improve the dynamic compliance of respiratory system. Thus, we proposed a randomized controlled trial to investigate the value of high flow nasal cannula in weaning AECOPD patients from invasive ventilation, with comparison of noninvasive ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Keywords
Weaning; Noninvasive ventilation; High flow nasal cannula

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
High flow nasal cannula
Arm Type
Experimental
Arm Description
High flow nasal cannula (HFNC) is a type of oxygen device, which provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation.
Arm Title
Noninvasive ventilation
Arm Type
Active Comparator
Arm Description
Non-invasive ventilation (NIV) refers to the provision of ventilatory support through the patient's upper airway using a mask. This technique is distinguished from those which bypass the upper airway with a tracheal tube, laryngeal mask, or tracheostomy and are therefore considered invasive.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Other Intervention Name(s)
High flow high humidity nasal cannula
Intervention Description
High-flow nasal cannula (HFNC) oxygen therapy is a recent technique delivering a high flow of heated and humidified gas. HFNC is simpler to use and apply than noninvasive ventilation (NIV) and appears to be a good alternative treatment for hypoxemic acute respiratory failure (ARF). HFNC is better tolerated than NIV, delivers high fraction of inspired oxygen (FiO2), generates a low level of positive pressure and provides washout of dead space in the upper airways, thereby improving mechanical pulmonary properties and unloading inspiratory muscles during ARF.
Intervention Type
Device
Intervention Name(s)
Noninvasive ventilation
Other Intervention Name(s)
Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation
Intervention Description
Non-invasive ventilation (NIV) is the use of airway support administered through a face (nasal) mask instead of an endotracheal tube. Inhaled gases are given with positive end-expiratory pressure often with pressure support or with assist control ventilation at a set tidal volume and rate. Numerous studies have shown this technique to be as effective as, and better tolerated than, intubation and mechanical ventilation in patients with exacerbations of COPD
Primary Outcome Measure Information:
Title
pH
Description
pH
Time Frame
change from the baseline pH within 48 hours
Title
PaCO2
Description
PaCO2 in mmHg
Time Frame
change from the baseline PaCO2 within 48 hours
Title
PaO2/FiO2
Description
partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg
Time Frame
change from the baseline PaO2/FiO2 within 48 hours
Title
HR
Description
Heart Rate in beats per minute
Time Frame
change from the baseline HR within 48 hours
Title
MAP
Description
mean arterial pressure in mmHg
Time Frame
change from the baseline MAP within 48 hours
Title
RR
Description
respiratory rate in breaths per minute
Time Frame
change from the baseline RR within 48 hours
Secondary Outcome Measure Information:
Title
duration of respiratory support
Description
hours of ventilator use
Time Frame
28 days
Title
Length of ICU stay
Description
Days of stay in ICU
Time Frame
28 days
Title
Mortality
Time Frame
28 days
Title
the patients' comfort score
Description
comfort score of using high flow nasal cannula or noninvasive ventilator, ranging from 1 to 10. 1 means very comfortable, 10 means very uncomfortable.
Time Frame
48 hours
Title
incidence of nasal trauma
Time Frame
28 days
Title
incidence of barotrauma
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intubated patients with Chronic obstructive pulmonary disease exacerbation Meeting extubation criteria (Pulmonary infection control window) Age > 21years and < 90 years Exclusion Criteria: Tracheotomy Combined with severe dysfunction of other organs, including heart, brain, liver, and renal failure; Hemodynamic instability Contraindication to NIV: cannot use mask, such as facial injury, burns or deformities; cannot cooperate with NIV such as delirium; copious secretions with weak cough ability; gastric over distention, and vomiting; Contraindication to HFNC: rhinitis, nasal congestion, deformities or blockage. Weak cough ability with copious secretions Refuse to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaozhi Wang, MD
Organizational Affiliation
Binzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Binzhou Medical University Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264003
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29237436
Citation
Zhu Y, Yin H, Zhang R, Wei J. High-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients with acute respiratory failure: a systematic review and meta-analysis of randomized controlled trials. BMC Pulm Med. 2017 Dec 13;17(1):201. doi: 10.1186/s12890-017-0525-0.
Results Reference
background
PubMed Identifier
27997805
Citation
Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
Results Reference
background
PubMed Identifier
28490869
Citation
Lv Y, Lv Q, Lv Q, Lai T. Pulmonary infection control window as a switching point for sequential ventilation in the treatment of COPD patients: a meta-analysis. Int J Chron Obstruct Pulmon Dis. 2017 Apr 24;12:1255-1267. doi: 10.2147/COPD.S126736. eCollection 2017.
Results Reference
background
PubMed Identifier
28860265
Citation
Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.
Results Reference
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Comparison of HFNC With NIV in Weaning COPD

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