Screening Elderly Patients for Weaning

NCT02243449 | Completed Phase 2

• 2 other identifiers: SENIOR0000001ClinicalTrials.gov Identifier:
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 8

Brief Summary

During weaning the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the time on ventilators is spent weaning. Studies support the use of screening protocols and tests of patient's ability to breathe spontaneously (SBTs) to identify weaning candidates. The investigators work demonstrates that once daily screening is the current standard of care. The conduct of daily ward rounds and once daily screening in ICUs is poorly aligned with the rapidly changing clinical status of critically ill patients. With respiratory therapists (RTs) in Canadian intensive care units (ICUs), a significant opportunity exists to screen patients more often, conduct more SBTs, and reduce the time spent on ventilators and in the ICU. Only one mechanical ventilation trial has focused on the elderly and no trial has evaluated weaning outcomes in the elderly and very elderly which may be influenced by the presence of comorbidities, frailty, malnutrition and treatment limitations. The investigators propose to conduct a pilot randomized trial in 100 elderly (\>/= 65 years) critically ill adults comparing 'once daily' screening to 'at least twice daily' screening in 8 adult ICUs. In the proposed trial, the investigators will (i) evaluate their ability to recruit elderly (\>/= 65 years) critically ill patients into a weaning trial and (ii) assess whether protocols can be adhered to similarly between elderly (65 to 80 years) and very elderly (\>80 years) trial participants. Moreover, they will also address generalizability issues in the conduct of mechanical ventilation research by evaluating potential biases associated with exclusion criteria and consent between elderly and very elderly patients and obtain preliminary estimates of differences in important clinical outcomes between elderly and very elderly participants.

Conditions

Critically Ill

Keywords

mechanical ventilation; weaning; elderly; critically ill; screening; spontaneous breathing trial; invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Recruit, on average, 2 elderly invasively ventilated, critically ill patients per ICU per month.

  As a feasibility trial, the investigators propose to assess feasibility metrics that reflect their ability to consent, enroll and recruit elderly and very elderly invasively ventilated patients and evaluate adherence to the study protocols in preparation for launching a large scale screening RCT including whether they can recruit invasively ventilated elderly (age \>/= 65 years) critically ill adults into a weaning trial comparing the alternative screening strategies.

  12 months

Secondary Outcomes (1)

• Adhere to the assigned screening protocols in both study arms.

  12 months

Other Outcomes (4)

• Proportion of enrolled elderly and very elderly trial participants

  12 months

• Proportion of consents obtained and declined for trial participation

  12 months

• Rates and reasons for trial exclusion

  12 months

Study Arms (2)

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: At least twice daily screening

Interventions

Once daily screening PROCEDURE

In the 'once daily screening arm', 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. The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, continuous positive airway pressure (CPAP) less than or equal to 5 cm H2O or PS less than or equal to 8 cm H2O with PEEP less than or equal to 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will be asked to choose one technique to be used for patients enrolled at their centre.

Once daily screening

At least 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. The initial SBT will be conducted in the same manner as in the once daily screening arm. The subsequent SBTs will be 30 -120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP \< to 5 cm H2 O or PS \< 8 cm H2 O with PEEP \< 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and with the use of different humidification strategies. Each centre will be asked to choose one technique for all patients enrolled at their centre.

At least twice daily screening

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The investigators will include:
• elderly (age \>/= 65 years) critically ill adults
• receiving invasive mechanical ventilation for at least 24 hours who can breathe spontaneously on Pressure Support (PS) or trigger 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).
• patients must be receiving \</= 70% inspired oxygen
• and a positive end-expiratory pressure of \</= 12 cm H2O (Table 2). .

You may not qualify if:

• The investigators will exclude patients who have already undergone extubation or an SBT, are unlikely to benefit (e.g. moribund, expected brain death), on automated weaning modes, participating in studies with a weaning protocol, and those who can not be optimized with regard to sedation and mobilization.
• Specifically, we will exclude patients:
• 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,
• who were previously enrolled in this trial,
• patients who have already undergone an SBT or

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (8)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

St Joseph's Hospital

Hamilton, Ontario, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Hôpital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Universite Hopitalier de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

• Burns KEA, Wong JTY, Dodek P, Cook DJ, Lamontagne F, Cohen A, Mehta S, Kho ME, Hebert PC, Aslanian P, Friedrich JO, Brochard L, Rizvi L, Hand L, Meade MO, Amaral AC, Seely AJ; Canadian Critical Care Trials Group. Frequency of Screening for Weaning From Mechanical Ventilation: Two Contemporaneous Proof-of-Principle Randomized Controlled Trials. Crit Care Med. 2019 Jun;47(6):817-825. doi: 10.1097/CCM.0000000000003722.

  PMID: 30920411 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Karen E. A. Burns, MD, FRCPC

  St. Michael's Hospital (Toronto, Canada)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: September 18, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

CA (8)