Frequency of Screening and SBT Technique Trial

NCT02399267 | Unknown

• 1 other identifier: FAST-001
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 10

Brief Summary

The requirement for invasive mechanical ventilation is a defining feature of critical illness. Liberation or weaning is the process during which the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time spent on mechanical ventilation is dedicated to weaning. Limiting the duration of invasive ventilation has been identified as a key research priority in critical care. Studies support the use of screening protocols (once daily vs. usual care) to identify weaning candidates and the conduct of tests of patient's ability to breathe spontaneously (SBTs). While once daily screening is the current standard of care in national intensive care units (ICUs), it is poorly aligned with the 24/7 ICU care environment wherein a critically ill patients' status can change from hour to hour. Only one large trial has compared alternative SBT techniques \[T-piece vs PS (Pressure Support)\]. No trial has compared a strategy of more frequent screening to once daily screening or alternative SBT techniques. The presence of respiratory therapists (RTs) 24/7 in North American ICUs presents a unique opportunity to screen more frequently, conduct more frequent SBTs, and determine the optimal strategy to liberate critically ill adults from invasive ventilation. The investigators propose to conduct a pilot randomized trial in 100 critically ill adults comparing 'once daily' screening to 'at least twice daily' screening and PS vs. T-piece SBTs in 12 Canadian ICUs. In the proposed trial, the investigators will (i) assess their ability to recruit critically ill adults who can breathe spontaneously or initiate breaths on one of several commonly used modes of ventilation into the trial, (ii) evaluate clinician's ability to implement the trial as designed, (iii) assess current practices in sedation, analgesia and delirium management and timing of patient mobilization prior to conducting screening assessments, (iv) identify barriers (clinician, institutional) to enrolling patients, (v) characterize trial participants based on weaning difficulty, and (vi) obtain preliminary estimates of the impact of the alternative screening and SBT strategies on clinically important outcomes.

Conditions

Critically Ill

Keywords

mechanical ventilation; weaning; critically ill; spontaneous breathing trial; screening; invasive ventilation; SBT technique

Outcome Measures

Primary Outcomes (1)

• Recruitment metrics as measured by number of critically ill patients enrolled per ICU per month

  Assess the investigative team's ability to recruit, on average, 2 invasively ventilated, critically ill adults who can breathe spontaneously or initiate breaths on one of several commonly used modes of ventilation into the trial, per ICU ment per month.

  24 Months

Secondary Outcomes (5)

• Adherence to protocol as measured by rate of protocol violations

  24 Months

• Current practices regarding sedation, analgesics, delirium and mobilization as assessed using a checklist prior to screening

  24 Months

• Enrollment Barriers as measured by consent rates and presence of exclusion criteria

  24 Months

• Characterize Weaning as simple, difficult or prolonged according to the Task Force on Weaning definitions

  24 Months

• Clinically Important Outcomes

  24 Months

Study Arms (4)

Once daily screening

ACTIVE COMPARATOR

In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hours of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol.

Procedure: Once daily screening

At least twice daily screening

EXPERIMENTAL

In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 06:00 - 08:00 hours and 13:00 - 15:00 hours daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hours of the scheduled screening period. Additional screening trials in the 'at least twice daily' screening arm will be permitted at the discretion of the clinical team (RTs and physicians). Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol.

Procedure: Twice daily screening

PS SBTs

ACTIVE COMPARATOR

In the 'PS SBTs arm', RTs will conduct SBTs using only PS =\< 8 cm H2O with PEEP =\< 5 cm H2O. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol.

Procedure: PS SBTs

T-piece SBTs

ACTIVE COMPARATOR

In the 'T-piece SBTs arm', RTs will conduct SBTs using only T-piece. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol.

Procedure: T-piece SBTs

Interventions

Once daily screening PROCEDURE

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.

Once daily screening

Twice daily screening PROCEDURE

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.

At least twice daily screening

PS SBTs PROCEDURE

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

PS SBTs

T-piece SBTs PROCEDURE

Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece.

T-piece SBTs

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will include patients who are:
• receiving invasive mechanical ventilation for \>= 24 hours.
• capable of initiating spontaneous breaths on Pressure Support (PS) or Proportional Assist Ventilation (PAV) or triggering breaths on volume or pressure Assist Control (AC), volume or pressure Synchronized Intermittent Mandatory Ventilation (SIMV) ± PS, Pressure Regulated Volume Control (PRVC) or (Airway Pressure Release Ventilation) APRV,
• with a fraction of inspired oxygen (FiO2) of =\< 70% and
• with a positive end-expiratory pressure (PEEP) of =\< 12 cm H2O.

You may not qualify if:

• The investigators will exclude patients who are
• admitted after cardiopulmonary arrest or with brain death or expected brain death,
• who have evidence of myocardial ischemia in the 24 hour period before enrollment,
• who have received continuous invasive mechanical ventilation for \>= 2 weeks,
• who have a tracheostomy in situ at the time of screening,
• who are receiving sedative infusions for seizures or alcohol withdrawal,
• who require escalating doses of sedative agents,
• who are receiving neuromuscular blockers or who have known quadriplegia, paraplegia or 4 limb weakness or paralysis preventing active mobilization (e.g., active range of motion, exercises in bed, sitting at edge of bed, transferring from bed to chair, standing, marching in place, ambulating),
• who are moribund (e.g., at imminent risk for death) or who have limitations of treatment (e.g., withdrawal of support, do not reintubate order, however, do not resuscitate orders will be permitted),
• who have profound neurologic deficits (e.g. large intracranial stroke or bleed) or Glasgow Coma Scale (GCS) \< 6,
• who are using modes that automate SBT conduct,
• who are current enrolled in a confounding study that includes a weaning protocol, or
• who were previously enrolled in this trial,
• patients who have already undergone an SBT or who are on settings compatible with an SBT (T-piece, CPAP without PS (any level), or PS (=\< 8 cm H2O regardless of PEEP)
• patients who have already undergone extubation \[planned, unplanned (e.g. self, accidental)\] during the same ICU admission.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (10)

Longbeach Memorial Hospital

Long Beach, California, 90806, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, United States

Location

St Paul's Hospital

Vancouver, British Columbia, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

St. Joseph's Hospital, Toronto

Toronto, Ontario, Canada

Location

Universite de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (3)

• Burns KEA, Wong J, Rizvi L, Lafreniere-Roula M, Thorpe K, Devlin JW, Cook DJ, Seely A, Dodek PM, Tanios M, Piraino T, Gouskos A, Kiedrowski KC, Kay P, Mitchell S, Merner GW, Mayette M, D'Aragon F, Lamontagne F, Rochwerg B, Turgeon A, Sia YT, Charbonney E, Aslanian P, Criner GJ, Hyzy RC, Beitler JR, Kassis EB, Kutsogiannis DJ, Meade MO, Liebler J, Iyer-Kumar S, Tsang J, Cirone R, Shanholtz C, Hill NS; Canadian Critical Care Trials Group. Frequency of Screening and Spontaneous Breathing Trial Techniques: A Randomized Clinical Trial. JAMA. 2024 Dec 3;332(21):1808-1821. doi: 10.1001/jama.2024.20631.

  PMID: 39382222 DERIVED

• Burns KEA, Lafrienier-Roula M, Hill NS, Cook DJ, Seely AJE, Rochwerg B, Mayette M, D'Aragon F, Devlin JW, Dodek P, Tanios M, Gouskos A, Turgeon AF, Aslanian P, Sia YT, Beitler JR, Hyzy R, Criner GJ, Kassis EB, Tsang JLY, Meade MO, Liebler JM, Wong JTY, Thorpe KE; Canadian Critical Care Trials Group. Frequency of screening and SBT Technique Trial-North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan. Trials. 2023 Oct 2;24(1):626. doi: 10.1186/s13063-023-07079-5.

  PMID: 37784109 DERIVED

• Burns KEA, Rizvi L, Cook DJ, Seely AJE, Rochwerg B, Lamontagne F, Devlin JW, Dodek P, Mayette M, Tanios M, Gouskos A, Kay P, Mitchell S, Kiedrowski KC, Hill NS; Canadian Critical Care Trials Group. Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial. Trials. 2019 Oct 11;20(1):587. doi: 10.1186/s13063-019-3641-8.

  PMID: 31604480 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Burns, MD, FRCPC

  St. Michael's Hopsital, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2015
• First Posted: March 26, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

US (2); CA (8)