Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial

Abstract

Rationale In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followed by conduct of an SBT. However, once daily (OD) screening is poorly aligned with the continuous care provided in most intensive care units (ICUs) and the best SBT technique for clinicians to use remains controversial. Objectives To identify the optimal screening frequency and SBT technique to wean critically ill adults in the ICU. Methods We aim to conduct a multicenter, factorial design randomized controlled trial with concealed allocation, comparing the effect of both screening frequency (once versus at least twice daily [ALTD]) and SBT technique (Pressure Support [PS] + Positive End-Expiratory Pressure [PEEP] vs T-piece) on the time to successful extubation (primary outcome) in 760 critically ill adults who are invasively ventilated for at least 24 h in 20 North American ICUs. In the OD arm, respiratory therapists (RTs) will screen study patients between 06:00 and 08:00 h. In the ALTD arm, patients will be screened at least twice daily between 06:00 and 08:00 h and between 13:00 and 15:00 h with additional screens permitted at the clinician’s discretion. When the SBT screen is passed, an SBT will be conducted using the assigned technique (PS + PEEP or T-piece). We will follow patients until successful extubation, death, ICU discharge, or until day 60 after randomization. We will contact patients or their surrogates six months after randomization to assess health-related quality of life and functional status. Relevance The around-the-clock availability of RTs in North American ICUs presents an important opportunity to identify the optimal SBT screening frequency and SBT technique to minimize patients’ exposure to invasive ventilation and ventilator-related complications. Trial registration Clinical Trials.gov, NCT02399267. Registered on Nov 21, 2016 first registered.

Biosignal-Based Digital Biomarkers for Prediction of Ventilator Weaning Success

“…Although many predictive indices and clinical tools are already in use [1,[13][14][15][16][17][18][19][20][21][22], >20% of the patients who have fulfilled the classic weaning criteria require reintubation [14,[23][24][25]. The predictive performance decreases in patients with multi-organ dysfunction, older age, prolonged MV, and severe illness [26][27][28][29][30][31].…”

Frequency of screening and SBT Technique Trial—North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan

“…This is an update to the protocol for the Frequency of Screening and Spontaneous Breathing Trial (SBT) Technique Trial—North American Weaning Collaborative (FAST-NAWC) trial, which was originally published in Trials [ 1 ]. As originally planned, participants in the pilot factorial design FAST trial [ 2 ] will be reported on in the FAST-NAWC trial.…”

“…We will follow patients until successful extubation, death, ICU discharge, or until day 60 after randomization. We will contact patients or their surrogates 6 months after randomization to assess health-related quality of life (HRQoL) and functional status [ 1 ].…”

“…This outcome is important to clinicians and citizens because it signals timely and safe liberation from the ventilator [ 3 – 5 ]. We defined successful extubation as the time when unsupported, spontaneous breathing began and was sustained for ≥ 48 h after extubation or disconnection in patients with tracheostomy [ 1 ]. The secondary objectives are to compare the effect of screening frequencies and SBT techniques on time to first passing an SBT, ICU mortality, hospital and 90-day mortality [ 6 ], total duration of mechanical ventilation, ICU and hospital length of stay, use of noninvasive ventilation after extubation, ventilator associated pneumonia, adverse events, self-extubation, tracheostomy, reintubation, prolonged ventilation at days 14 and 21, ICU readmission [ 7 , 8 ], proportion receiving sedatives or analgesics or antipsychotics or screened positive for delirium at key time points, health related-quality of life (HRQoL) using the EuroQol EQ-5D, and a functional status assessment using the Functional Independence Measure (FIM) assessed at 6 months after randomization [ 9 – 12 ].…”

“…With regard to SBT conduct, once participants pass a screening assessment, they were expected to undergo an SBT according to the assigned treatment. We modified the trial protocol, to specify that COVID-19 negative patients would undergo an initial SBT according to treatment assignment using the 2 techniques that are most commonly utilized in practice internationally (PS + PEEP vs. T-piece) and being evaluated in the FAST-NAWC trial [ 1 , 15 – 17 ]. We specified that COVID-19 positive patients would undergo SBTs with either [no support on the ventilator [(i.e., PS = 0 cm H 2 O + PEEP = 0 cm H 2 O or CPAP = 0 cm H 2 O) or PS + PEEP SBTs].…”