Epidemiological Survey of Children With Prolonged Mechanical Ventilation.

Prolonged Mechanical Ventilation Clinical Trial

Official title:

Epidemiological Survey of Children With Prolonged Mechanical Ventilation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511741
• Other study ID #: CHFudanUCWM
• Status: Completed
• Start date: November 15, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: July 1, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

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

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Related Conditions & MeSH terms

• Prolonged Mechanical Ventilation

Intervention

Other:
• no intervention, it is an observational study.
no intervention, it is an observational study.

Locations

Country	Name	City	State
China	Children' hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	mortality rate	The mortality rate among patients received prolonged mechanical ventilation.	During the procedure (about 2 years)
Secondary	the length of prolonged mechanical ventilaton	The length of prolonged mechanical ventilaton among patients would be recorded during the hospitalization and after discharging.	During the procedure (about 2 years)