Clinical Assessment Method in Patients Using Non-invasive Ventilation

NCT04053777 | Unknown

• 1 other identifier: GIRH-NIV201906
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study of recording the respiratory parameters of patients when receiving non-invasive ventilation and analyze the relationship between those parameters and clinical outcomes.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Changes of visual analogue scale score before and after using non-invasive ventilation

  Visual analogue scale score is used to represent the subjective dyspnea of patient. Scores range between 0 and 10 and higher scores are attributed to less dyspnea.

  1 hour

Secondary Outcomes (4)

• Changes of respiratory rate before and after using non-invasive ventilation

  1 hour

• Changes of SpO2 before and after using non-invasive ventilation

  1 hour

• Changes of tidal volume before and after using non-invasive ventilation

  1 hour

• Changes of heart rate before and after using non-invasive ventilation

  1 hour

Study Arms (1)

NIV group

Patients receiving non-invasive ventilation in the hospital or at home

Device: non-invasive ventilation

Interventions

non-invasive ventilation DEVICE

Noninvasive positive pressure ventilation used assist/control mode to treat chronic respiratory disease.

NIV group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypercapnic respiratory failure who need to use non-invasive ventilation.

You may qualify if:

• Age 18-80, males and females
• Patients with hypercapnic respiratory failure
• Willing to participate in the study.
• Being able to provide informed consent.

You may not qualify if:

• Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.
• Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)
• Subjects who participated in another trial within 30 days prior to the planned start of the study

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Rongchang Chen, MD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Lili Guan, PhD

CONTACT

+8613422288665; nickguanll@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: August 20, 2019
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

CN (1)