NCT04511741

Brief Summary

Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2.6 years

First QC Date

August 10, 2020

Last Update Submit

March 17, 2026

Conditions

Prolonged Mechanical Ventilation

Keywords

prolonged mechanical ventilationChildren

Outcome Measures

Primary Outcomes (1)

  • the cause of prolonged mechanical ventilation

    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 Outcomes (2)

  • mortality rate

    During the procedure (about 2 years)

  • the length of prolonged mechanical ventilaton

    During the procedure (about 2 years)

Study Arms (2)

invasive mechanical ventilation

Other: no intervention, it is an observational study.

non invasive mechanical ventilation

Other: no intervention, it is an observational study.

Interventions

no intervention, it is an observational study.OTHER

no intervention, it is an observational study.

invasive mechanical ventilationnon invasive mechanical ventilation

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children' hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

  • Racca F, Berta G, Sequi M, Bignamini E, Capello E, Cutrera R, Ottonello G, Ranieri VM, Salvo I, Testa R, Wolfler A, Bonati M; LTV Pediatric Italian Network. Long-term home ventilation of children in Italy: a national survey. Pediatr Pulmonol. 2011 Jun;46(6):566-72. doi: 10.1002/ppul.21401. Epub 2010 Dec 30.

    PMID: 21560263BACKGROUND

Study Officials

  • Chen Weiming

    children' hospital of Fudan university

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 13, 2020

Study Start

November 15, 2020

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations

CN(1)