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High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients

Primary Purpose

Patients With Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-flow nasal cannula
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Respiratory Insufficiency focused on measuring respiratory insufficiency, High-flow nasal cannula

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with chronic respiratory insufficiency who require long-term oxygen therapy.

Age 18-85 years old. Agree to participate in this study.

Exclusion Criteria:

- 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

Sites / Locations

  • Shanghai Tenth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control

HFNC

Arm Description

Pure oxygen by nasal cannula group

oxygen by High-flow nasal cannula

Outcomes

Primary Outcome Measures

Improve dyspnea score
Length of hospital stay

Secondary Outcome Measures

Full Information

First Posted
November 21, 2016
Last Updated
November 21, 2016
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02972021
Brief Title
High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients
Official Title
High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
To confirm HFNC used in patients with chronic respiratory insufficiency oxygen therapy than the general nasal catheter oxygen and the difference between what better. We set up a point of research in the tertiary hospitals, secondary hospitals and primary hospitals to explore the different levels of HFNC in the application of the efficacy of the hospital there are differences and what is better. To further clarify the promotion of HFNC to secondary hospitals and primary hospitals have no meaning. Patients with chronic respiratory insufficiency who required long-term oxygen therapy were randomized to a randomized, controlled, multicentre clinical trial of HFNC with nasal oxygen therapy. Analysis and comparison of HFNC and general nasal catheter oxygen in the treatment of chronic respiratory insufficiency there is no difference, HFNC in different grades of hospital use is consistent. Research methods: 4.1 Subjects: Chronic respiratory insufficiency required long-term oxygen therapy to Shanghai Tenth People's Hospital and multi-center hospital patients. 4.2 Study sample size: 100 samples were collected from each of the three test centers. Of which 150 cases of nasal oxygen therapy, HFNC 150 cases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Respiratory Insufficiency
Keywords
respiratory insufficiency, High-flow nasal cannula

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Other
Arm Description
Pure oxygen by nasal cannula group
Arm Title
HFNC
Arm Type
Experimental
Arm Description
oxygen by High-flow nasal cannula
Intervention Type
Device
Intervention Name(s)
High-flow nasal cannula
Primary Outcome Measure Information:
Title
Improve dyspnea score
Time Frame
up to 12 months after oxygen therapy
Title
Length of hospital stay
Time Frame
up to 12 months after oxygen therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients with chronic respiratory insufficiency who require long-term oxygen therapy. Age 18-85 years old. Agree to participate in this study. Exclusion Criteria: - 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HU PENG, MD
Phone
+821666304586
Email
denkepeng@189.cn
First Name & Middle Initial & Last Name or Official Title & Degree
YUANZHUO CHEN, MD
Phone
+821666304586
Email
chenyuanzhuo021@hotmail.com
Facility Information:
Facility Name
Shanghai Tenth Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HU PENG, MD
Email
chenyuanzhuo021@hotmail.com

12. IPD Sharing Statement

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High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients

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