High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02972021
Collaborator
(none)
300
1
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High-flow nasal cannula
N/A

Detailed Description

  1. To confirm HFNC used in patients with chronic respiratory insufficiency oxygen therapy than the general nasal catheter oxygen and the difference between what better.

  2. 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.

  3. 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.

  4. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: control

Pure oxygen by nasal cannula group

Device: High-flow nasal cannula

Experimental: HFNC

oxygen by High-flow nasal cannula

Device: High-flow nasal cannula

Outcome Measures

Primary Outcome Measures

  1. Improve dyspnea score [up to 12 months after oxygen therapy]

  2. Length of hospital stay [up to 12 months after oxygen therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Tenth Hospital Shanghai Shanghai China 200072

Sponsors and Collaborators

  • Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chen Yuanzhuo, department of emergency, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT02972021
Other Study ID Numbers:
  • shsk20160722
First Posted:
Nov 23, 2016
Last Update Posted:
Nov 23, 2016
Last Verified:
Nov 1, 2016
Keywords provided by Chen Yuanzhuo, department of emergency, Shanghai 10th People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2016