CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 940 enrolled
Drug / intervention
Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trialother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04758546
NCT04758546N/ACompleted

Customizing Spontaneous Breathing Trial After Aggressive Readiness Criteria Hastens Weaning in Low and Intermediate Risk Patients With Prevention: A Randomized Trial (SPEED-UP Trial).

Gonzalo Hernandez Martinez·interventional·Posted Feb 17, 2021·Updated Apr 6, 2023

In Brief

A clinical study evaluating Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trial for Weaning Failure. Completed, enrolled 940 participants across 1 site.

Detailed Summary

Hypothesis: 1. In patients with less than 4 high risk factors for reintubation excluding body mass index \>30 and hypercapnia during the spontaneous breathing trial (SBT) (low and intermediate risk for extubation failure), who receive preventive therapy with high flow nasal cannula (HFNC), the use of SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O Vs PS 5 + PEEP 0 cm H2O), increase the proportion of patients with simple weaning (extubation after the first SBT). 2. In patients with low and intermediate risk for extubation failure, who receive preventive therapy with HFNC, the use of Walsh screening criteria reduces the mechanical ventilation time compared with the use of Boles criteria. Study design: This is a multicenter randomized open trial with 4 arms. 1. Screening with PaO2/FiO2 \> 180 and PEEP ≤ 10cm H2O; SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O). 2. Screening with PaO2/FiO2 \> 180 and PEEP ≤ 10 cm H2O; SBT with "LOW minimal ventilator settings" (PS 5 + PEEP 0 cm H2O). 3. Screening with PaO2/FiO2 ≥ 150 and PEEP ≤ 8 cm H2O; SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O). 4. Screening with PaO2/FiO2 ≥ 150 and PEEP ≤ 8 cm H2O; SBT with "LOW minimal ventilator settings" (PS 5 + PEEP 0 cm H2O). Primary Outcome Measure: 1. \- Percentage of first spontaneous breathing trial tolerated. 2. \- Time on mechanical ventilation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWeaning Failure
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 17, 2021
Enrollment StartMar 1, 2021
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.4 years ago

Interventions

Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trialother

Aggressive screening criteria: Walsh Conservative screening criteria: Boles High minimal ventilatory settings: pressure Support 8 + positive end-expiratory pressure 5 Low minimal ventilatory settings: pressure support 5