NCT03436095

Brief Summary

Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration 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

January 25, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

February 10, 2018

Last Update Submit

February 10, 2018

Conditions

Keywords

Bundledifficult ventilator weaning

Outcome Measures

Primary Outcomes (1)

  • Bundle measures can solve the problem of difficult-weaning patients with Non neurogenic disease in ICU.

    Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.

    From June 1st 2017 to June 30 2020

Study Arms (3)

research group

bundle measures to help patient to weaning ventilator

Other: bundle measures

historical control group

retrospect the patients who were difficult to wean from ventilator and collect some materials to compare.

Other: bundle measures

External control group

contrast other same level hospitals measures to patients who are difficult to wean ventilator.

Other: bundle measures

Interventions

Implementation of bundle measures to improve the successful rate of weaning ventilator

External control grouphistorical control groupresearch group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

difficult-weaning patients with Non neurogenic disease in ICU.

You may qualify if:

  • Older than 16 years of age, ventilator therapy more than 1 weeks,ventilator parameters up to Weaning standard, repeated more than 3 times Spontaneous Breathing Test(SBT) not successful, or within a short period of time within a week of successful weaning, no other new incentives to re machine induced delayed more than 1 months or more offline.

You may not qualify if:

  • Mechanical ventilation patients who are clearly defined as neurological disorders or advanced tumor wasting diseases, as well as those without informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Study Officials

  • Meng Xinke

    study principal investigator Shenzhen Second Hospital

    STUDY DIRECTOR

Central Study Contacts

Feng Yongwen

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 10, 2018

First Posted

February 19, 2018

Study Start

January 25, 2017

Primary Completion

November 30, 2019

Study Completion

July 30, 2020

Last Updated

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations