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Clinical Trials/NCT03458364
NCT03458364
Completed
N/A

Comparison of High Flow Nasal Cannula With Noninvasive Ventilation in Facilitating Weaning Chronic Obstructive Pulmonary Disease From Invasive Ventilation: a Prospective Randomized Controlled Study

Jie Li1 site in 1 country42 target enrollmentJanuary 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Sponsor
Jie Li
Enrollment
42
Locations
1
Primary Endpoint
pH
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
July 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jie Li
Responsible Party
Sponsor Investigator
Principal Investigator

Jie Li

Clinical education coordinator

Rush University Medical Center

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

Outcomes

Primary Outcomes

pH

Time Frame: change from the baseline pH within 48 hours

pH

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

RR

Time Frame: change from the baseline RR within 48 hours

respiratory rate in breaths per minute

HR

Time Frame: change from the baseline HR within 48 hours

Heart Rate in beats per minute

PaCO2

Time Frame: change from the baseline PaCO2 within 48 hours

PaCO2 in mmHg

MAP

Time Frame: change from the baseline MAP within 48 hours

mean arterial pressure in mmHg

Secondary Outcomes

  • incidence of barotrauma(28 days)
  • the patients' comfort score(48 hours)
  • Mortality(28 days)
  • incidence of nasal trauma(28 days)
  • duration of respiratory support(28 days)
  • Length of ICU stay(28 days)

Study Sites (1)

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