Clinical trial NCT03458364: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Keywords: Weaning; Noninvasive ventilation; High flow nasal cannula
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Binzhou Medical University
First posted: 2018-03-08
Enrollment: 42
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pH
timeFrame: change from the baseline pH within 48 hours
measure: PaCO2
timeFrame: change from the baseline PaCO2 within 48 hours
measure: PaO2/FiO2
timeFrame: change from the baseline PaO2/FiO2 within 48 hours
measure: HR
timeFrame: change from the baseline HR within 48 hours
measure: MAP
timeFrame: change from the baseline MAP within 48 hours
measure: RR
timeFrame: change from the baseline RR within 48 hours
Secondary outcomes:
measure: duration of respiratory support
timeFrame: 28 days
measure: Length of ICU stay
timeFrame: 28 days
measure: Mortality
timeFrame: 28 days
measure: the patients' comfort score
timeFrame: 48 hours
measure: incidence of nasal trauma
timeFrame: 28 days
measure: incidence of barotrauma
timeFrame: 28 days
Other outcomes:
Locations:
city: Yantai
country: China
facility: Binzhou Medical University Hospital
state: Shandong
Study officials:
affiliation: Binzhou Medical University
name: Xiaozhi Wang, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.