Comparison of HFNC With NIV in Weaning COPD

NCT ID: NCT03458364

Last Updated: 2018-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-07-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Noninvasive ventilation

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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High flow high humidity nasal cannula Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Binzhou Medical University

OTHER

Sponsor Role collaborator

Jie Li

OTHER

Sponsor Role lead

Responsible Party

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Jie Li

Clinical education coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaozhi Wang, MD

Role: STUDY_CHAIR

Binzhou Medical University

Locations

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Binzhou Medical University Hospital

Yantai, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 29237436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27997805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28490869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28860265 (View on PubMed)

Other Identifiers

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HFNC-002

Identifier Type: -

Identifier Source: org_study_id

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