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Effect of a Personalized Weaning Strategy on Weaning Success

NCT05719194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 691

Last updated 2026-05-08

No results posted yet for this study

Summary

Weaning from mechanical ventilation is a daily challenge in intensive care units, as it can take up to 50% of the total duration of ventilation. The longer the duration of ventilation is, the more there is complication related with it.

Even when the spontaneous breathing trial is succeeded, 10 to 20% of extubations are failed and requires re-intubation.

There is two different ways to assess if the patient is capable of breathing by its own : T-piece which can be considered as hard to succeed (it can delay extubation for some patients) or pressure support ventilation with no PEEP which can be too easy and lead to an extubation too early.

Studies have identified risk factors of weaning induced pulmonary oedema wich is one of the main cause of failed extubation (up to 60%).

The purpose of P-WEAN is to evaluate whether a personalized strategy for weaning from mechanical ventilation, including daily search for weaning criteria and individualization of the weaning modality (T-piece or pressure support ventilation with zero PEEP) based on the existence of WIPO risk factors (obesity, COPD, heart disease) improves weaning success compared with usual practice.

Conditions

  • Weaning
  • Mechanical Ventilation
  • Intubation

Interventions

OTHER

Standard SBT

Weaning strategy in accordance with the care practices of the department, regarding the assessment of weaning criteria, SBT and extubation modalities.

OTHER

SBT with T-piece or PSV

\- Risk factors of WIPO Step 1 : Daily assessment of weaning criteria in accordance with the study protocol. Step 2 : Spontaneous breathing trial with T-piece for an hour. Measure of protein and haemoglobin by blood sample before and after the trial. Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful. If SBT failed : no extubation and new SBT the next day. Optimization of cardiac function or fluid overload will be in charge of the investigator. \- No risk factors of WIPO Step 1 : Daily assessment of weaning criteria in accordance with the study protocol. Step 2 : Spontaneous breathing trial with pressure support ventilation (pressure support from 5 to 8 cmH20 - PEEP at 0 cmH20) for an hour. Step 3 : Reconnect the patient to the ventilator for at least 30 minutes and then extubate if SBT is successful.

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Jules Audard · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2026-03-11
Completion
2026-03-11

Countries

  • France

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 NCT05719194 on ClinicalTrials.gov