Clinical Assessment Method in Patients Using Non-invasive Ventilation

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

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 Overview

• Status: Unknown
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: non-invasive ventilation

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Lili Guan, PhD; Phone Number: +8613422288665; Email: nickguanll@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangzhou Institute of Respiratory Disease
      • Contact: Rongchang Chen; Phone Number: +8615622236759; Email: chenrcstatekeylab@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NIV group; Patients receiving non-invasive ventilation in the hospital or at home	Device: non-invasive ventilation; Noninvasive positive pressure ventilation used assist/control mode to treat chronic respiratory disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Chair: Rongchang Chen, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Anticipated): September 15, 2020
• Study Completion (Anticipated): September 15, 2020

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: GIRH-NIV201906

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No