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Comparison of HFNC With NIV in Weaning COPD

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ClinicalTrials.gov Identifier: NCT03458364
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Binzhou Medical University
Information provided by (Responsible Party):
Jie Li, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation Device: High flow nasal cannula Device: Noninvasive ventilation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : July 30, 2018

Arm Intervention/treatment
Experimental: High flow nasal cannula
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.
Device: High flow nasal cannula
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.
Other Name: High flow high humidity nasal cannula

Active Comparator: Noninvasive ventilation
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.
Device: Noninvasive ventilation
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
Other Name: Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation




Primary Outcome Measures :
  1. pH [ Time Frame: change from the baseline pH within 48 hours ]
    pH

  2. PaCO2 [ Time Frame: change from the baseline PaCO2 within 48 hours ]
    PaCO2 in mmHg

  3. PaO2/FiO2 [ Time Frame: change from the baseline PaO2/FiO2 within 48 hours ]
    partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg

  4. HR [ Time Frame: change from the baseline HR within 48 hours ]
    Heart Rate in beats per minute

  5. MAP [ Time Frame: change from the baseline MAP within 48 hours ]
    mean arterial pressure in mmHg

  6. RR [ Time Frame: change from the baseline RR within 48 hours ]
    respiratory rate in breaths per minute


Secondary Outcome Measures :
  1. duration of respiratory support [ Time Frame: 28 days ]
    hours of ventilator use

  2. Length of ICU stay [ Time Frame: 28 days ]
    Days of stay in ICU

  3. Mortality [ Time Frame: 28 days ]
  4. the patients' comfort score [ Time Frame: 48 hours ]
    comfort score of using high flow nasal cannula or noninvasive ventilator, ranging from 1 to 10. 1 means very comfortable, 10 means very uncomfortable.

  5. incidence of nasal trauma [ Time Frame: 28 days ]
  6. incidence of barotrauma [ Time Frame: 28 days ]


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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458364


Locations
China, Shandong
Binzhou Medical University Hospital
Yantai, Shandong, China, 264003
Sponsors and Collaborators
Jie Li
Binzhou Medical University
Investigators
Study Chair: Xiaozhi Wang, MD Binzhou Medical University

Publications:
Responsible Party: Jie Li, Clinical education coordinator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03458364     History of Changes
Other Study ID Numbers: HFNC-002
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jie Li, Rush University Medical Center:
Weaning; Noninvasive ventilation; High flow nasal cannula

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases