The Clinical Study of Bundle Measures to Improve the Success Rate of Patients With Difficult Ventilator Weaning

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.

Study Overview

• Status: Unknown
• Conditions: Weaning Failure
• Intervention / Treatment: Other: bundle measures

Detailed Description

Older than 16 years of age, ventilator therapy more than 1 weeks, Ventilator parameters meet the standard of ventilator removal, repeated more than 3 times SBT not successful, or within a short period of time within a week of successful weaning, no other new incentives to need ventilator support again, and delayed weaning from ventilator more than 1 months.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Second People's Hospital
      • Contact: Yang Guozhao; Phone Number: +86075583003435; Email: yangguozhao123@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

difficult-weaning patients with Non neurogenic disease in ICU.

Description

Inclusion Criteria:

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.

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Exclusion Criteria:

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

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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
research group; bundle measures to help patient to weaning ventilator	Other: bundle measures; Implementation of bundle measures to improve the successful rate of weaning ventilator
historical control group; retrospect the patients who were difficult to wean from ventilator and collect some materials to compare.	Other: bundle measures; Implementation of bundle measures to improve the successful rate of weaning ventilator
External control group; contrast other same level hospitals measures to patients who are difficult to wean ventilator.	Other: bundle measures; Implementation of bundle measures to improve the successful rate of weaning ventilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital
• Investigators: Study Director: Meng Xinke, study principal investigator Shenzhen Second Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: February 10, 2018
• First Submitted That Met QC Criteria: February 10, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 10, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Bundle; difficult ventilator weaning
• Other Study ID Numbers: 20173357201816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Study Report

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No