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Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Primary Purpose

Lung Diseases, Obstructive

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)
nasal catheter or Venturi mask
Sponsored by
Li Xuyan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Obstructive focused on measuring Acute exacerbation of chronic obstructive pulmonary disease, Nasal high flow therapy, Oxygen therapy

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nasal high flow therapy

Conventional oxygen therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Length of hospital stay
Costs of hospitalization expenses

Full Information

First Posted
May 7, 2015
Last Updated
January 14, 2020
Sponsor
Li Xuyan
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1. Study Identification

Unique Protocol Identification Number
NCT02439333
Brief Title
Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Xuyan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive
Keywords
Acute exacerbation of chronic obstructive pulmonary disease, Nasal high flow therapy, Oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal high flow therapy
Arm Type
Active Comparator
Arm Description
AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day.
Arm Title
Conventional oxygen therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)
Intervention Description
Nasal high flow therapy
Intervention Type
Device
Intervention Name(s)
nasal catheter or Venturi mask
Intervention Description
Conventional oxygen therapy
Primary Outcome Measure Information:
Title
Treatment failure criteria
Description
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)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
30 days
Title
Costs of hospitalization expenses
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AECOPD patients. The results of blood gas analysis showed pH ≥7.35, PO2< 60mmHg, PaCO2> 45mmHg. Exclusion Criteria: 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing Sun, MD
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33262584
Citation
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.
Results Reference
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Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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