NCT02972021

Brief Summary

Chronic respiratory insufficiency in patients with advanced disease to the late treatment depends mainly on mechanical ventilation and other high intensity respiratory support therapy. Strengthen the stability of chronic respiratory insufficiency intervention can reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of respiratory support therapy. There is little research on the role of HFNC in oxygen therapy for chronic respiratory insufficiency. Our previous studies have found the potential value of HFNC in chronic respiratory insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals in an effort to confirm that HFNC can improve the prognosis of patients with chronic respiratory insufficiency compared with nasal oxygen therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 21, 2016

Last Update Submit

November 21, 2016

Conditions

Keywords

respiratory insufficiencyHigh-flow nasal cannula

Outcome Measures

Primary Outcomes (2)

  • Improve dyspnea score

    up to 12 months after oxygen therapy

  • Length of hospital stay

    up to 12 months after oxygen therapy

Study Arms (2)

control

OTHER

Pure oxygen by nasal cannula group

Device: High-flow nasal cannula

HFNC

EXPERIMENTAL

oxygen by High-flow nasal cannula

Device: High-flow nasal cannula

Interventions

HFNCcontrol

Eligibility Criteria

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

You may qualify if:

  • \- Patients with chronic respiratory insufficiency who require long-term oxygen therapy.
  • Age 18-85 years old. Agree to participate in this study.

You may not qualify if:

  • \- Patients with advanced respiratory support (invasive mechanical ventilation, noninvasive mechanical ventilation) indications Cardiovascular disease caused by respiratory insufficiency Immune dysfunction caused by respiratory insufficiency Tumor-induced respiratory insufficiency People with disturbance of consciousness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tenth Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

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
department of emergency

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 23, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations