NCT03003559

Brief Summary

For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.9 years

First QC Date

December 22, 2016

Last Update Submit

January 13, 2020

Conditions

COPD Exacerbation

Keywords

COPD ExacerbationHigh Flow OxygenNasal Cannulamild

Outcome Measures

Primary Outcomes (1)

  • endotracheal intubation demand rate

    90days

Secondary Outcomes (1)

  • actual endotracheal intubation rate

    90days

Study Arms (2)

High flow nasal cannula

EXPERIMENTAL

High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37.

Device: High flow nasal cannula

Nasal cannula

NO INTERVENTION

Nasal cannula;set oxygen flow to keep SpO2 90-95%

Interventions

High flow nasal cannulaDEVICE

High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.

Also known as: High flow oxygen
High flow nasal cannula

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AECOPD; pH≥7.35, PaCO2\>45 mmHg

You may not qualify if:

  • Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

Related Publications (2)

  • Xia J, Yang H, Zhan Q, Fan Y, Wang C. High-flow nasal cannula may prolong the length of hospital stay in patients with hypercapnic acute COPD exacerbation. Respir Med. 2023 Dec;220:107465. doi: 10.1016/j.rmed.2023.107465. Epub 2023 Nov 11.

    PMID: 37956934DERIVED

  • Xia J, Gu S, Lei W, Zhang J, Wei H, Liu C, Zhang H, Lu R, Zhang L, Jiang M, Hu C, Cheng Z, Wei C, Chen Y, Lu F, Chen M, Bi H, Liu H, Yan C, Teng H, Yang Y, Liang C, Ge Y, Hou P, Liu J, Gao W, Zhang Y, Feng Y, Tao C, Huang X, Pan P, Luo H, Yun C, Zhan Q. High-flow nasal cannula versus conventional oxygen therapy in acute COPD exacerbation with mild hypercapnia: a multicenter randomized controlled trial. Crit Care. 2022 Apr 15;26(1):109. doi: 10.1186/s13054-022-03973-7.

    PMID: 35428349DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Qingyuan Zhan, M.D.

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingen Xia, Master

CONTACT

13466396561xiajingen_00632@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of Pulmonary and Critical care medicine ward 4

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 28, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)