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Clinical Assessment Method in Patients Using Non-invasive Ventilation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04053777
Enrollment
150
Registered
2019-08-13
Start date
2019-08-20
Completion date
2020-09-15
Last updated
2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

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.

Interventions

DEVICEnon-invasive ventilation

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

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of visual analogue scale score before and after using non-invasive ventilation1 hourVisual 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

MeasureTime frameDescription
Changes of respiratory rate before and after using non-invasive ventilation1 hourThe 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 ventilation1 hourOxygen saturation is the fraction of \[oxygen\]-saturated hemoglobin relative to total hemoglobin in the blood.
Changes of tidal volume before and after using non-invasive ventilation1 hourTidal 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 heart rate before and after using non-invasive ventilation1 hourHeart rate is the speed of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm).

Countries

China

Contacts

Primary ContactLili Guan, PhD
nickguanll@qq.com+8613422288665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026