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Speeding the Weaning up: Aggressive Screening Criteria and Higher Minimal Ventilatory Settings.

NCT04758546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 940

Last updated 2023-04-06

No results posted yet for this study

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.

Conditions

  • Weaning Failure

Interventions

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

  • Gonzalo Hernandez Martinez

    lead OTHER

Principal Investigators

  • Gonzalo Hernandez · University Hospital Virgen de la Salud

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758546 on ClinicalTrials.gov