The Frequency of Screening and SBT Technique Trial: The FAST Trial

NCT02969226 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2018-12-05

No results posted yet for this study

Summary

Background: The sickest patients who are admitted to an intensive care unit (ICU) often require assistance with their breathing. When patients start to get better, they gradually do more of the breathing and the machine does less-this is called weaning. Although ventilator use saves lives, the longer it is used, the more complications can occur. Clinicians aim to wean patients from ventilators in a timely and safe manner. In most ICUs, patients are screened (looked at) once per day to see if they are ready to undergo a weaning test (using a variety of techniques) to see if the breathing tube can be removed. Screening more than once per day may allow more weaning tests to be conducted. Knowing the best way to do a weaning test is important because some methods may better determine who can have the breathing tube removed safely. At present, we don't know the best way to help our sickest patients to wean from ventilators.

Patients: Adults in North American ICUs who are on ventilators for at least 24 hours and who can take breaths on their own.

Interventions: Patients in our study will receive one type of screening and one type of weaning test at random. In the 'once daily' screening groups, clinicians will screen patients each morning. In the 'two or more times daily screening' groups, patients will be screened in the morning, afternoon, and whenever else clinicians wish to screen. When screening criteria are met, patients will undergo one of two weaning tests with low ventilator support or no support.

Outcomes: The main outcome of this study will be the time for patients to be successfully removed from the ventilator.

Relevance: For patients, this study will clarify the best way to remove them from ventilators in a timely and safe manner. For clinicians and our health care systems, this study holds promise to improve how critically ill patients are weaned from breathing machines.

Conditions

  • Critically Ill

Interventions

PROCEDURE

Once daily screening

RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.

PROCEDURE

Twice daily screening

In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.

PROCEDURE

PS SBTs

Patients are assigned a SBT technique. All SBTs for these patients must be conducted on PS \>0 and =\< 8 cm H2O with PEEP\>0 and =\< 5 cm H2O

PROCEDURE

T-piece SBTs

Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator)

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Karen Burns, MD, FRCPC · St. Michael's Hospital (Toronto, Canada)

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-18
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969226 on ClinicalTrials.gov