Comparison of HFNC With NIV in Weaning COPD

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
• Intervention / Treatment: Device: High flow nasal cannula; Device: Noninvasive ventilation

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
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Yantai, Shandong, China, 264003
      • Binzhou Medical university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH	pH	change from the baseline pH within 48 hours
PaCO2	PaCO2 in mmHg	change from the baseline PaCO2 within 48 hours
PaO2/FiO2	partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg	change from the baseline PaO2/FiO2 within 48 hours
HR	Heart Rate in beats per minute	change from the baseline HR within 48 hours
MAP	mean arterial pressure in mmHg	change from the baseline MAP within 48 hours
RR	respiratory rate in breaths per minute	change from the baseline RR within 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		28 days
duration of respiratory support	hours of ventilator use	28 days
Length of ICU stay	Days of stay in ICU	28 days
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.	48 hours
incidence of nasal trauma		28 days
incidence of barotrauma		28 days

Collaborators and Investigators

• Sponsor: Jie Li
• Collaborators: Binzhou Medical University
• Investigators: Study Chair: Xiaozhi Wang, MD, Binzhou Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 30, 2018

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (ACTUAL): March 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Weaning; Noninvasive ventilation; High flow nasal cannula
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: HFNC-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No