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Status unknownNCT04053777Updated Oct 23, 2019

Clinical Assessment Method in Patients Using Non-invasive Ventilation

An observational study in Respiratory Failure, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-23.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Respiratory Failure
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In context

Respiratory Insufficiency

1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 556 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 165 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • NIV group

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

    Device: non-invasive ventilation

Interventions

  • Devicenon-invasive ventilation

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

Secondary outcomes

  1. 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.

    Time frame: 1 hour

  2. 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.

    Time frame: 1 hour

  3. 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.

    Time frame: 1 hour

  4. 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).

    Time frame: 1 hour

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Study locations

1 of 1 sites recruiting
  • Guangzhou Institute of Respiratory Disease
    Guangzhou, Guangdong 510000, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04053777
Responsible party
Guan Lili (Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Aug 13, 2019
Start date
Aug 20, 2019
Primary completion
Sep 15, 2020 (estimated)
Completion
Sep 15, 2020 (estimated)
Last update
Oct 23, 2019

Study contacts

Lili Guan, PhD
Contact
nickguanll@qq.com
+8613422288665
Rongchang Chen, MD
study chair · The First Affiliated Hospital of Guangzhou Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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