NCT02439333

Brief Summary

The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 \< 60mmHg,PaCO2\>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. The high flow nasal respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. This study is a prospective randomized study. AECOPD patients with no severe respiratory failure are treated with NHF and conventional oxygen therapy respectively. The target is that NHF can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

May 7, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

January 18, 2020

Status Verified

May 1, 2018

Enrollment Period

4 years

First QC Date

May 7, 2015

Last Update Submit

January 14, 2020

Conditions

Lung Diseases, Obstructive

Keywords

Acute exacerbation of chronic obstructive pulmonary diseaseNasal high flow therapyOxygen therapy

Outcome Measures

Primary Outcomes (1)

  • Treatment failure criteria

    Patients with mild respiratory acidosis (7.25 \< pH \< 7.35) with obvious dyspnea (accessory respiratory muscle involvement, breathing rate greater than 25 beats per minute)

    5 days

Secondary Outcomes (2)

  • Length of hospital stay

    30 days

  • Costs of hospitalization expenses

    30 days

Study Arms (2)

Nasal high flow therapy

ACTIVE COMPARATOR

AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day.

Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)

Conventional oxygen therapy

ACTIVE COMPARATOR

AECOPD patients with no severe respiratory insufficiency are given conventional oxygen therapy such as nasal catheter or venturi mask for at least 15 hours per day.

Device: nasal catheter or Venturi mask

Interventions

Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)DEVICE

Nasal high flow therapy

Nasal high flow therapy
nasal catheter or Venturi maskDEVICE

Conventional oxygen therapy

Conventional oxygen therapy

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AECOPD patients.
  • The results of blood gas analysis showed pH ≥7.35, PO2\< 60mmHg, PaCO2\> 45mmHg.

You may not qualify if:

  • The study case has been incorporated into the hospital again.
  • Refused to the NHF therapy.
  • The Glasgow score \< 8.
  • Severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, DIC, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of respiratory and critical care medicine,Beijing Chao-yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

  • Li XY, Tang X, Wang R, Yuan X, Zhao Y, Wang L, Li HC, Chu HW, Li J, Mao WP, Wang YJ, Tian ZH, Liu JH, Luo Q, Sun B, Tong ZH. High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 24;15:3051-3061. doi: 10.2147/COPD.S283020. eCollection 2020.

    PMID: 33262584DERIVED

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Bing Sun, MD

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

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
Sponsor-Investigator

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 8, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 15, 2019

Last Updated

January 18, 2020

Record last verified: 2018-05

Locations

CN(1)