Clinical Assessment Method in Patients Using Non-invasive Ventilation

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04053777
• Other study ID #: GIRH-NIV201906
• Status: Recruiting
• Start date: August 20, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2019
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Lili Guan, PhD
• Phone: +8613422288665
• Email: nickguanll[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18-80, males and females

2. Patients with hypercapnic respiratory failure

3. Willing to participate in the study.

4. Being able to provide informed consent.

Exclusion Criteria:

1. Subjects with severe heart failure, severe arrhythmias, unstable angina, and malignant comorbidities.

2. Subjects with significantly impaired cognitive function and are unable to fulfill the study requirement (unable to provide informed consent)

3. Subjects who participated in another trial within 30 days prior to the planned start of the study

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• non-invasive ventilation
Noninvasive positive pressure ventilation used assist/control mode to treat chronic respiratory disease.

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of respiratory rate before and after using non-invasive ventilation	The respiratory rate is the rate at which breathing occurs. This is usually measured in breaths per minute.	1 hour
Secondary	Changes of SpO2 before and after using non-invasive ventilation	Oxygen saturation is the fraction of [oxygen]-saturated hemoglobin relative to total hemoglobin in the blood.	1 hour
Secondary	Changes of tidal volume before and after using non-invasive ventilation	Tidal volume is the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied.This is usually measured in mini Liter.	1 hour
Secondary	Changes of heart rate before and after using non-invasive ventilation	Heart rate is the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm).	1 hour