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Comparison of HFNC With NIV in Weaning COPD

Not Applicable
Completed
Conditions
Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Interventions
Device: High flow nasal cannula
Device: Noninvasive ventilation
Registration Number
NCT03458364
Lead Sponsor
Jie Li
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High flow nasal cannulaHigh flow nasal cannulaHigh 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.
Noninvasive ventilationNoninvasive ventilationNon-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.
Primary Outcome Measures
NameTimeMethod
pHchange from the baseline pH within 48 hours

pH

PaO2/FiO2change from the baseline PaO2/FiO2 within 48 hours

partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg

RRchange from the baseline RR within 48 hours

respiratory rate in breaths per minute

HRchange from the baseline HR within 48 hours

Heart Rate in beats per minute

PaCO2change from the baseline PaCO2 within 48 hours

PaCO2 in mmHg

MAPchange from the baseline MAP within 48 hours

mean arterial pressure in mmHg

Secondary Outcome Measures
NameTimeMethod
incidence of barotrauma28 days
the patients' comfort score48 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.

Mortality28 days
incidence of nasal trauma28 days
duration of respiratory support28 days

hours of ventilator use

Length of ICU stay28 days

Days of stay in ICU

Trial Locations

Locations (1)

Binzhou Medical University Hospital

🇨🇳

Yantai, Shandong, China

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