Assessment of Process and Outcome of Protocol-based Weaning From Mechanical Ventilation in the Medical Patients

NCT05134467 | Recruiting

• 1 other identifier: SMC 2017-08-141-009
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, observational study to describe characteristics of weaning process and factors associated with duration of weaning and its outcomes in all consecutive adult (aged 19 years and older) patients receiving mechanical ventilation for at least two calendar days in medical intensive care units since November 2017. Details of the patients' weaning process and spontaneous breathing trial (SBT) in addition to clinical, laboratory, and outcome data will be collected in a specified format on the day of the assessment by respiratory care practitioners.

Conditions

Ventilator Lung

Outcome Measures

Primary Outcomes (2)

• Successful weaning

  Extubation without death or reintubation within the next 7 days of spontaneous breathing trial or discharge from intensive care unit without invasive mechanical ventilation (MV) within 7 days, whichever comes first for intubated patients and as spontaneous ventilation through tracheostomy without any MV during 7 consecutive days or discharged with spontaneous breathing, whichever comes first for patients with tracheostomy after the first separation attempt

  6 months from MV

• Weaning outcomes by the Weaning Outcome according to a New Definition (WIND) classification

  Group 1 (short weaning), the first attempt result in the termination of the weaning process within 1 day Group 2 (difficult weaning), the weaning process is completed after more than 1 day but in less than 1 week after the first separation attempt Group 3 (prolonged weaning), the weaning process is still not terminated 7 days after the first separation attempt.

  6 months from MV

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients receiving mechanical ventilation for at least two calendar days in medical intensive care units

You may qualify if:

• All consecutive adult patients receiving mechanical ventilation for at least two calendar days in medical intensive care units

You may not qualify if:

• None

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Related Publications (1)

• Na SJ, Ko RE, Nam J, Ko MG, Jeon K. Factors associated with prolonged weaning from mechanical ventilation in medical patients. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221117005. doi: 10.1177/17534666221117005.

  PMID: 35943272 DERIVED

Study Officials

• Kyeongman Jeon

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyeongman Jeon

CONTACT

82-2-3410-2423; kjeon@skku.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 26, 2021
• Study Start: November 1, 2017
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: November 26, 2021

Record last verified: 2021-11

Locations

KR (1)