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

Ventilator Lung Clinical Trial

Official title:

Prospective, Single-center, Observational Study on the Assessment of Process and Outcome of Protocol-based Weaning From Mechanical Ventilation in the Medical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05134467
• Other study ID #: SMC 2017-08-141-009
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: September 30, 2029

Study information

• Verified date: November 2021
• Source: Samsung Medical Center
• Contact: Kyeongman Jeon
• Phone: 82-2-3410-2423
• Email: kjeon[@]skku.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Study design and objectives: This is a prospective, single-center, observational study to address key issues relating to weaning from mechanical ventilation (MV) in medical intensive care units. This study aims to describe characteristics of weaning process and factors associated with duration of weaning and its outcomes.

Inclusion criteria: All consecutive adult (aged 19 years and older) patients receiving MV for at least two calendar days in medical intensive care units since November 2017 will be screened daily.

Exclusion criteria: None

Protocol based weaning process: Every morning, respiratory care practitioners assess a patient's readiness to be weaned from MV in all patients who received MV for more than 24 h. First, the patient's condition, including improvement of the underlying cause of respiratory failure, clinical stability, and adequacy of pulmonary function and oxygenation are comprehensively evaluated. If the patient fulfill all of the criteria of readiness for weaning trials, SBT is conducted according to the protocol to assess the ability of the patient for spontaneous breathing; if the patient does not fulfill the criteria, no further weaning process is performed on that day. Our hospital performed the T-piece trial, in which supplemental oxygen was provided through a T-piece connected to an endotracheal tube or tracheostomy tube, on all patients until July 2019. From July 2019, SBT has been performed with inspiratory pressure augmentation (the ventilator is set with a pressure support of 8 cmH2O and zero-positive end-expiratory pressure) for patients who received MV through an endotracheal tube according to the revised weaning protocol. Tolerance for SBT is evaluated for 30 min on the first attempt and for 2 h after the second attempt, regardless of the method used. However, if a sign of SBT failure is identified even before the target duration, the trial is immediately stopped. When the patient satisfies all the criteria for successful SBT, extubation is performed immediately, and supplemental oxygen is provided by a high-flow nasal cannula for at least 24 h in patients with an endotracheal tube; administration of supplemental oxygen is continued through a T-piece system in patients with tracheostomy. Decisions about when and how to perform a tracheostomy are left to the discretion of the clinicians and are not guided by a prescribed algorithm.

Data collection and clinical outcomes: Clinical, laboratory, and outcome data will be prospectively collected by a trained study coordinator. The demographics of the patients and major cause of intubation will be evaluated and recorded by the physicians on the day of MV support initiation. Details of the patients' weaning readiness and SBT will be recorded in a specified format on the day of the assessment by respiratory care practitioners. The values of the MV setting and respiratory parameters are synchronized to the hospital electronic medical chart and recorded every hour, and we will collect the values at 8 am on the day of the first SBT. Clinical outcomes will be assessed by the successful weaning defined according to Weaning Outcome according to a New Definition (WIND) study and WIND classification of weaning.

Ethical Approval and Patient Consent: The Institutional Review Board of Samsung Medical Center approved this study and waived the requirement for informed consent, because this study is pure observation and data collection program that involves no more than minimal risk, the data collected are part of routine clinical care that would not adversely affect rights and welfare of subject, and the data will be anonymized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Ventilator Lung

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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