NCT03458364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

March 2, 2018

Last Update Submit

August 20, 2018

Conditions

Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Keywords

Weaning; Noninvasive ventilation; High flow nasal cannula

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • duration of respiratory support

    28 days

  • Length of ICU stay

    28 days

  • Mortality

    28 days

  • the patients' comfort score

    48 hours

  • incidence of nasal trauma

    28 days

  • +1 more secondary outcomes

Study Arms (2)

High flow nasal cannula

EXPERIMENTAL

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

Noninvasive ventilation

ACTIVE COMPARATOR

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

Interventions

High flow nasal cannulaDEVICE

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.

Also known as: High flow high humidity nasal cannula
High flow nasal cannula
Noninvasive ventilationDEVICE

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

Also known as: Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation
Noninvasive ventilation

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intubated patients with Chronic obstructive pulmonary disease exacerbation
  • Meeting extubation criteria (Pulmonary infection control window)
  • Age \> 21years and \< 90 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binzhou Medical University Hospital

Yantai, Shandong, 264003, China

Location

Related Publications (4)

  • 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.

    PMID: 29237436BACKGROUND

  • 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.

    PMID: 27997805BACKGROUND

  • 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.

    PMID: 28490869BACKGROUND

  • 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.

    PMID: 28860265BACKGROUND

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Xiaozhi Wang, MD

    Binzhou Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical education coordinator

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 8, 2018

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 30, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations

CN(1)