Parallel Pilot Trials of Screening Frequency for Liberation from Mechanical Ventilation the RELEASE Trial and SENIOR Trial Protocols

Burns, Karen E. A.; Wong, Jody

doi:10.4172/2167-0870.1000236

Cited by 2 publications

(4 citation statements)

References 33 publications

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“…To address the concerns that elderly critically ill patients may experience more adverse events and are less likely to be enrolled in weaning trials due to comorbidities and treatment limitations, we conducted 2 parallel, multicenter, pilot screening frequency trials comparing once vs. at least twice daily screening in 100 elderly patients >65 years (SENIOR Trial; ClinicalTrials.gov NCT02243449) and 50 non-elderly patients <65 years (RELEASE Trial; NCT02001220) [26]. In the multicenter RELEASE (10 ICUs) and SENIOR trials (11 ICUs), we prioritized evaluation of screening frequency, recognizing that a 'change in screening culture' was warranted and allowed personnel in participating centers to use their preferred SBT technique.…”

Section: Discussionmentioning

confidence: 99%

“…Specifically, we revised and expanded the criterion excluding patients who already had undergone an SBT to also exclude patients who are already on SBT equivalent settings. This criterion is necessary to ensure that protocol-directed screening identifies patients for an SBT-a population that may benefit from more frequent screening [26]. We identified that more patients in the SENIOR trial were excluded due to age-related illnesses.…”

Section: Discussionmentioning

confidence: 99%

“…[2] To assess compliance with once daily and at least twice daily screening assessment protocols and the risk of contamination in the once daily arm. Similarly, we will assess compliance with PS and Tpiece SBT protocols and the risk of contamination in either arm, [3] To quantify potential co-interventions in this unblinded study (sedation, analgesia and delirium management and timing of mobilization) that may lead to performance bias and may require protocolization or detailed documentation in a future, large scale weaning trial, Tertiary objectives [4] To identify barriers (clinician and institutional) to recruitment, [5] To classify trial participants as those who require (i) simple, (ii) difficult or (iii) prolonged weaning using established definitions [21], [6] To obtain preliminary estimates of the impact of the alternative screening ('once daily' vs. 'at least twice daily') and SBT techniques (PS ± PEEP vs. T-piece off ventilator with no CPAP/PEEP) on important outcomes [e.g., time to first SBT and first successful SBT, time to first extubation and successful extubation [24], total duration of mechanical ventilation, ICU and hospital length of stay, ICU and hospital mortality, the use of noninvasive ventilation (NIV) after extubation, and weaning-related complications (self-extubation, reintubation, tracheostomy) [24][25][26][27].…”

Section: Pilot Trial Objectivesmentioning

confidence: 99%

“…For patients who are enrolled under deferred consent, consent will be sought as soon as possible after randomization. A similar hybrid consent model was used in two multicenter, pilot screening frequency trials comparing once daily screening to at least twice daily screening [26].…”

Section: Informed Consentmentioning

confidence: 99%

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Frequency of Screening and SBT Technique Trial

Kea¹,

Rizvi²,

Dodek³

et al. 2016

J Clin Trials

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Rationale: Research supports the use of screening protocols to identify patients who are candidates for weaning from mechanical ventilation, and the use of spontaneous breathing trials (SBTs) to predict ability to breathe spontaneously. However, once daily screening is poorly aligned with 24-hour continuous care in the intensive care unit (ICU) environment and the most effective SBT technique is not known. The optimal strategy to liberate our sickest patients from ventilators remains to be determined. Objectives:To assess our ability to recruit critically ill adults and adhere to the screening and SBT protocols. Methods:We propose a pilot, factorial design, randomized trial comparing once-daily versus at least twice daily screening and pressure support (PS) ± positive end-expiratory pressure (PEEP) (inspiratory ± expiratory support) or T-piece (no support) as the SBT technique in critically ill adults who are invasively ventilated for at least 24 hours in 11 North American ICUs. Respiratory Therapists (RTs) will screen all enrolled patients between 06:00 and 08:00 hours daily to identify SBT candidates. Patients in the at least twice daily screening arms will also be screened between 13:00 and 15:00 hours; additional screening will be permitted at clinician's discretion. Once a screening assessment is passed, an SBT will be conducted with the assigned technique. Outcomes:The study will be considered feasible if at least 1 to 2 patients per ICU per month are recruited and if the screening and SBT protocols are adhered to >80% of the time.Relevance: The availability of RTs in ICUs presents an important opportunity to screen patients more frequently, conduct more frequent SBTs, and reduce the duration of invasive ventilation and ICU stay.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Pilot Trial Objectivesmentioning

confidence: 99%

Section: Informed Consentmentioning

confidence: 99%

See 2 more Smart Citations

Frequency of Screening and SBT Technique Trial

Kea¹,

Rizvi²,

Dodek³

et al. 2016

J Clin Trials

View full text Add to dashboard Cite

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Frequency of Screening for Weaning From Mechanical Ventilation: Two Contemporaneous Proof-of-Principle Randomized Controlled Trials*

Burns

Wong

Dodek

et al. 2019

Critical Care Medicine

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Objectives: It is unknown whether more frequent screening of invasively ventilated patients, identifies patients earlier for a spontaneous breathing trial, and shortens the duration of ventilation. We assessed the feasibility of conducting a large trial to evaluate screening frequency in critically ill adults in the North American context. Design: We conducted two contemporaneous, multicenter, pilot, randomized controlled trials (the LibeRation from MEchanicaL VEntilAtion and ScrEening Frequency [RELEASE] and Screening Elderly PatieNts For InclusiOn in a Weaning [SENIOR] trials) to address concerns regarding the potential for higher enrollment, fewer adverse events, and better outcomes in younger patients. Setting: Ten and 11 ICUs in Canada, respectively. Patients: Parallel trials of younger (RELEASE < 65 yr) and older (SENIOR ≥ 65 yr) critically ill adults invasively ventilated for at least 24 hours. Interventions: Each trial compared once daily screening to “at least twice daily” screening led by respiratory therapists. Measurements and Main Results: In both trials, we evaluated recruitment (aim: 1–2 patients/month/ICU) and consent rates, reasons for trial exclusion, protocol adherence (target: ≥ 80%), crossovers (aim: ≤ 10%), and the effect of the alternative screening frequencies on adverse events and clinical outcomes. We included 155 patients (53 patients [23 once daily, 30 at least twice daily] in RELEASE and 102 patients [54 once daily, 48 at least twice daily] in SENIOR). Between trials, we found similar recruitment rates (1.32 and 1.26 patients/month/ICU) and reasons for trial exclusion, high consent and protocol adherence rates (> 92%), infrequent crossovers, and few adverse events. Although underpowered, at least twice daily screening was associated with a nonsignificantly faster time to successful extubation and more successful extubations but significantly increased use of noninvasive ventilation in both trials combined. Conclusions: Similar recruitment and consent rates, few adverse events, and comparable outcomes in younger and older patients support conduct of a single large trial in North American ICUs assessing the net clinical benefits associated with more frequent screening.

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Parallel Pilot Trials of Screening Frequency for Liberation from Mechanical Ventilation the RELEASE Trial and SENIOR Trial Protocols

Cited by 2 publications

References 33 publications

Frequency of Screening and SBT Technique Trial

Frequency of Screening and SBT Technique Trial

Frequency of Screening for Weaning From Mechanical Ventilation: Two Contemporaneous Proof-of-Principle Randomized Controlled Trials*

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