Epidemiological Survey of Children With Prolonged Mechanical Ventilation.

August 3, 2023 updated by: Children's Hospital of Fudan University
Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation. There is a lack of data on children with long-term mechanical ventilation in China.The investigators conducted this study to investigate the clinical characteristics of children with long-term mechanical ventilation in China. The investigators conducted a multicenter clinical epidemiological survey.The study included PICU wards in major children's hospitals in China and investigated the causes of prolonged mechanical ventilation, the outcome of long-term mechanical ventilation.PMV definition: continuous invasive or noninvasive ventilation time ≥ 21 days, daily ≥ 6 hours.

Study Type

Observational

Enrollment (Actual)

346

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chen Weiming
  • Phone Number: 13817551034

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children' hospital of Fudan university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients who need prolonged mechanical ventilation aged from one month to 18 years old.

Description

Inclusion Criteria: patients who need prolonged mechanical ventilation aged from one month to 18 years old.

-

Exclusion Criteria: Other clinical conditions not suitable to participate considered by investigator.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
invasive mechanical ventilation
Other: no intervention, it is an observational study.
no intervention, it is an observational study.
non invasive mechanical ventilation
Other: no intervention, it is an observational study.
no intervention, it is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the cause of prolonged mechanical ventilation
Time Frame: At enrollment
This is a categorical variable. The reasons for the prolonged mechanical ventilation wolud be recorded, includes neuromuscular diseases, upper respiratory airway diseases, central nervous system diseases, lower respiratory airway diseases, abnormal ventilation control diseases.
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rate
Time Frame: During the procedure (about 2 years)
The mortality rate among patients received prolonged mechanical ventilation.
During the procedure (about 2 years)
the length of prolonged mechanical ventilaton
Time Frame: During the procedure (about 2 years)
The length of prolonged mechanical ventilaton among patients would be recorded during the hospitalization and after discharging.
During the procedure (about 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Director: Chen Weiming, Children' hospital of Fudan university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHFudanUCWM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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