NCT02981589

Brief Summary

The main purpose of the present study was to explore the weaning failure rate from invasive mechanical ventilation and to identify risk factors of weaning failure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

10.4 years

First QC Date

December 1, 2016

Last Update Submit

June 30, 2021

Conditions

Patients Requiring Endotracheal Intubation and Invasive Mechanical Ventilation

Outcome Measures

Primary Outcomes (3)

  • Weaning failure rate

    3.5 years

  • Spontaneous breathing trial failure rate

    3.5 years

  • Extubation failure rate

    3.5 years

Secondary Outcomes (4)

  • ICU mortality

    3.5 years

  • Hospital mortality

    3.5 years

  • ICU length of stay

    3.5 years

  • Hospital length of stay

    3.5 years

Interventions

Invasive mechanical ventilationDEVICE

Invasive ventilation was performed to all eligible patients. When patients met predefined criteria, spontaneous breathing trial was performed. Given spontaneous breathing trial passed, patients were extubated; on the contrary, patients would continue to receive invasive ventilation. If patients had respiratory failure after extubation, reintubation and invasive ventilation were necessary.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring endotracheal intubation and invasive mechanical ventilation

You may qualify if:

  • Requiring endotracheal intubation and invasive mechanical ventilation

You may not qualify if:

  • Duration of invasive mechanical ventilation \< 48 hours；
  • Presence of tracheostomy；
  • Presence of upper airway obstruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory intensive care unit, Beijing Chao Yang Hospital Jingxi Campus

Beiling, China

RECRUITING

Related Publications (1)

  • Luo Z, Zheng Y, Yang L, Liu S, Zhu J, Zhao N, Pang B, Cao Z, Ma Y. Neutrophil/lymphocyte ratio is helpful for predicting weaning failure: a prospective, observational cohort study. J Thorac Dis. 2018 Sep;10(9):5232-5245. doi: 10.21037/jtd.2018.08.68.

    PMID: 30416770DERIVED

Study Officials

  • Zujin Luo, MD

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zujin Luo, MD

CONTACT

[email protected]

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

July 1, 2013

Primary Completion

December 1, 2023

Study Completion

March 31, 2024

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)