Clinical Assessment Method in Patients Using Non-invasive Ventilation

NCT ID: NCT04053777

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-20

Study Completion Date

2020-09-15

Brief Summary

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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

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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.

Conditions

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Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NIV group

Patients receiving non-invasive ventilation in the hospital or at home

non-invasive ventilation

Intervention Type DEVICE

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

Interventions

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non-invasive ventilation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Guan Lili

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rongchang Chen, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of Guangzhou Medical University

Locations

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Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lili Guan, PhD

Role: CONTACT

+8613422288665

Facility Contacts

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Rongchang Chen

Role: primary

+8615622236759

Other Identifiers

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GIRH-NIV201906

Identifier Type: -

Identifier Source: org_study_id

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