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

NCT04758546 | Completed DMC

• 1 other identifier: 7/10/2020 Nº 10
• Study Type: interventional
• Target: 940
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis:

1. 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. 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.
3. 3.Screening with PaO2/FiO2 \> 180 and PEEP ≤ 10cm H2O; SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O).
4. 4.Screening with PaO2/FiO2 \> 180 and PEEP ≤ 10 cm H2O; SBT with "LOW minimal ventilator settings" (PS 5 + PEEP 0 cm H2O).
5. 5.Screening with PaO2/FiO2 ≥ 150 and PEEP ≤ 8 cm H2O; SBT with "HIGH minimal ventilator settings" (PS 8 + PEEP 5 cm H2O).
6. 6.Screening with PaO2/FiO2 ≥ 150 and PEEP ≤ 8 cm H2O; SBT with "LOW minimal ventilator settings" (PS 5 + PEEP 0 cm H2O).
7. 7.\- Percentage of first spontaneous breathing trial tolerated.
8. 8.\- Time on mechanical ventilation.

Conditions

Weaning Failure

Outcome Measures

Primary Outcomes (2)

• Percentage of first spontaneous breathing trial tolerated

  1 month after intubation

• Time on mechanical ventilation

  1 month after intubation

Secondary Outcomes (5)

• Reintubation rate

  7 days after extubation

• Post-extubation respiratory failure rate

  7 days after extubation

• ICU and Hospital length of stay

  3 months after ICU and Hospital admission

• ICU and Hospital mortality rate

  3 months after ICU and Hospital admission

• Sepsis and multiorgan failure rate

  3 months after ICU and Hospital admission

Study Arms (4)

Aggressive screening criteria + high minimal ventilatory settings

EXPERIMENTAL

Diagnostic Test: Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trial

Aggressive screening criteria + low minimal ventilatory settings

EXPERIMENTAL

Diagnostic Test: Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trial

Conservative screening criteria + high minimal ventilatory settings

EXPERIMENTAL

Diagnostic Test: Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trial

Conservative screening criteria + low minimal ventilatory settings

ACTIVE COMPARATOR

Diagnostic Test: Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trial

Interventions

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

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

Aggressive screening criteria + high minimal ventilatory settings; Aggressive screening criteria + low minimal ventilatory settings; Conservative screening criteria + high minimal ventilatory settings; Conservative screening criteria + low minimal ventilatory settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on mechanical ventilation for more than 24 hours with \>= positive end-expiratory pressure 10.
• Patients with up to three high risk factors for extubation failure excluding hypercapnia during the spontaneous breathing trial and obese patients (BMI \>30).
• Patients fulfilling weaning criteria expected to have a spontaneous breathing trial in the following 24 hours.
• Patients expected to be prevented with high-flow oxygen therapy after extubation.

You may not qualify if:

• \<18 years old.
• Pregnant women.
• Tracheostomized patients.
• Accidental or self-extubated patients.
• Obese (BMI \>30) or hypercapnic patients during the spontaneous breathing trial.

Sponsors & Collaborators

• Gonzalo Hernandez Martinez: lead

Study Sites (1)

Hospital Virgen de la Salud

Toledo, Castille-La Mancha, 45007, Spain

Location

Related Publications (1)

• Hernandez Martinez G, Rodriguez P, Soto J, Caritg O, Castellvi-Font A, Mariblanca B, Garcia AM, Colinas L, Anon JM, Parrilla-Gomez FJ, Silva-Obregon JA, Masclans JR, Propin A, Cuadra A, Dalorzo MG, Rialp G, Suarez-Sipmann F, Roca O. Effect of aggressive vs conservative screening and confirmatory test on time to extubation among patients at low or intermediate risk: a randomized clinical trial. Intensive Care Med. 2024 Feb;50(2):258-267. doi: 10.1007/s00134-024-07330-w. Epub 2024 Feb 14.

  PMID: 38353714 DERIVED

MeSH Terms

Interventions

Weaning

Intervention Hierarchy (Ancestors)

Infant Nutritional Physiological Phenomena; Child Nutritional Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Gonzalo Hernandez

  University Hospital Virgen de la Salud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

ES (1)