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Clinical Trials/NCT04053777
NCT04053777
Unknown
N/A

Establishment and Validation of the Clinical Assessment Method in Patients Using Non-invasive Ventilation

The First Affiliated Hospital of Guangzhou Medical University1 site in 1 country150 target enrollmentAugust 20, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Enrollment
150
Locations
1
Primary Endpoint
Changes of visual analogue scale score before and after using non-invasive ventilation
Last Updated
6 years ago

Overview

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.

Detailed Description

Non-invasive positive pressure ventilation (NPPV) is undoubtedly one of the most important advances in mechanical ventilation technology in the past 30 years. Currently, NPPV has become an essential respiratory support technology in hospitals, and it is used in different fields, including respiratory and critical care, emergency care, anesthesia, and rehabilitation. Applications of NPPV are also gradually expanding from intensive care units (ICUs) and respiratory wards to use in other medical departments and at home. 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.

Registry
clinicaltrials.gov
Start Date
August 20, 2019
End Date
September 15, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Guan Lili

Principal Investigator

The First Affiliated Hospital of Guangzhou Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 1 hour

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.

Secondary Outcomes

  • Changes of tidal volume before and after using non-invasive ventilation(1 hour)
  • 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 heart rate before and after using non-invasive ventilation(1 hour)

Study Sites (1)

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