Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT

• ClinicalTrials.gov Identifier: NCT03118804
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: December 19, 2018
• Sponsor: Southeast University, China
• Information provided by (Responsible Party): Songqiao Liu, Southeast University, China

Tracking Information

• First Submitted Date: April 9, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: December 19, 2018
• Actual Study Start Date: October 18, 2016
• Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2017)

Weaning duration [ Time Frame: 48 hours ]

Time of weaning duration from SBT to weaning from mechanical ventilation

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
• Official Title: Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
• Brief Summary: To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation
• Detailed Description: 53 patients who ready to wean from mechanical ventilation were included in this study. The changes of lung tidal distribution during SBT with mechanical ventilation by EIT were recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients with mechanical ventilation admitted to ICU of Zhongda hospital
• Condition: Mechanical Ventilation

Intervention

Diagnostic Test: Assessment of Lung Tidal Distribution With EIT

Changes of lung tidal distribution during SBT with mechanical ventilation were recorded by EIT can be used to predict weaning success or failure

Study Groups/Cohorts

Weaning Guide by EIT

Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT

Intervention: Diagnostic Test: Assessment of Lung Tidal Distribution With EIT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 16, 2017): 53
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2018
• Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Intubated patients age between 18 years old and 80 years old
2. Duration of controlled mechanical ventilation≥ 24 h
3. Patients ready to wean from mechanical ventilation
4. Informed consent

Exclusion Criteria:

1. Pregnant women
2. Patients with malignant tumor
3. High paraplegia, neuromuscular lesions
4. Thoracic deformity, diaphragmatic hernia
5. Patients with ECMO
6. Patient participated in another interventional trial before enrollment

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03118804
• Other Study ID Numbers: 2016ZDSYLL064-Y01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Songqiao Liu, Southeast University, China
• Study Sponsor: Southeast University, China
• Collaborators: Not Provided

Investigators

• Principal Investigator: Liu Songqiao, PHD; Southeast University

• PRS Account: Southeast University, China
• Verification Date: December 2018