Clinical Assessment Method in Patients Using Non-invasive Ventilation

• Conditions: Respiratory Failure
• Interventions: Device: non-invasive ventilation

• Registration Number: NCT04053777
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-13
• Study Start: 2019-08-20
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIV group	non-invasive ventilation	Patients receiving non-invasive ventilation in the hospital or at home

Primary Outcome Measures

Name	Time	Method
Changes of visual analogue scale score before and after using non-invasive ventilation	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 Outcome Measures

Name	Time	Method
Changes of tidal volume before and after using non-invasive ventilation	1 hour	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.
Changes of respiratory rate before and after using non-invasive ventilation	1 hour	The respiratory rate is the rate at which breathing occurs. This is usually measured in breaths per minute.
Changes of SpO2 before and after using non-invasive ventilation	1 hour	Oxygen saturation is the fraction of \[oxygen\]-saturated hemoglobin relative to total hemoglobin in the blood.
Changes of heart rate before and after using non-invasive ventilation	1 hour	Heart rate is the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm).

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease; 🇨🇳 Guangzhou, Guangdong, China