Effect of a Personalized Weaning Strategy on Weaning Success

NCT05719194 | Recruiting

• 1 other identifier: P-Wean PHRC IR 2020 AUDARD
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

WIPO; Extubation; Spontaneous Breathing Trial; T-piece; Pressure Support Ventilation; Weaning strategy; Personalization

Outcome Measures

Primary Outcomes (1)

• Mortality at day 28, reintubation at 72 hours, ventilatory free days (VFDs) from first spontaneous breathing trial to day 28.

  Composite score including those three criteria such that mortality is a more severe outcome than reintubation and the number of VFDs, and reintubation is a more severe outcome than the number of VFDs

  28 days

Secondary Outcomes (11)

• Rate of extubation success after the first SBT.

  72 hours from first SBT

• Rate of reintubation

  72 hours from first SBT

• Rate of reintubation

  72 hours from extubation

• Reintubation rate within 7 days of extubation.

  7 days after extubation

• Time from first SBT to extubation.

  28 days

Other Outcomes (5)

• Rate of tracheostomy during the ICU stay.

  28 days

• Incidence of non-invasive ventilation or high-flow nasal oxygenation post-extubation, both prophylactic and curative.

  72 hours after extubation.

• Incidence of use for diuretics or beta-blockers for failed weaning trials or WIPO.

  28 days

Study Arms (2)

Standard intervention

ACTIVE COMPARATOR

Other: Standard SBT

Personalized intervention - WIPO risk factors vs no risk factors

EXPERIMENTAL

Other: SBT with T-piece or PSV

Interventions

Standard SBT OTHER

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

Standard intervention

SBT with T-piece or PSV OTHER

\- 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.

Personalized intervention - WIPO risk factors vs no risk factors

Eligibility Criteria

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

You may qualify if:

• Resolution or improvement of the condition that led to intubation, as judged by the clinician in charge of the patient.
• Hemodynamic stability, defined as systolic blood pressure between 90 and 160 mmHg, heart rate less than 140 beats/min, without or with low doses of vasopressors.
• Glasgow score of 13 or greater and Richmond Agitation-Sedation Scale (RASS) score between -1 and +1.
• Respiratory stability defined as: oxygen saturation \> 90% with inspired oxygen fraction ≤ 0.5 and PEEP ≤ 8 cmH2O, respiratory rate \< 35/min, spontaneous tidal volume \> 5 mL/kg, and peak inspiratory pressure ≤ 15 cmH2O.
• Few secretions (\< 3 aspirations in the past 8 hours).
• Effective cough.
• Negative leak test (\>100 mL or \>10%).
• No surgery planned within 72 hours.
• Patients with a social security plan.

You may not qualify if:

• Acute cerebral pathology requiring admission to intensive care and/or mechanical ventilation with tracheal intubation for neurological reasons (Glasgow score \<13 at the time of intubation or CT scan abnormality): hemorrhagic stroke without or with vascular malformation (aneurysm, arterio-venous malformation...), ischemic stroke, head trauma, cerebral anoxo-ischemia after cardiac arrest.
• Tetraplegic or paraplegic patients with lesion level higher than D8.
• Peripheral neuromuscular pathology (underlying myopathy or myasthenia).
• ICU's Neuromyopathy.
• Tracheostomy.
• Patients with a decision of non-reintubation or terminal intubation.
• Pregnant or lactating women.
• Patients already included in this study.
• Patients under guardianship, curatorship or safeguard of justice.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (9)

CHU de Bordeaux

Bordeaux, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

CHU de Grenoble

Grenoble, France

RECRUITING

CHU de Lille

Lille, France

RECRUITING

CHU de Lyon - Hôpital Lyon Sud

Lyon, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

CHU de Saint-Etienne

Saint-Etienne, France

RECRUITING

CHU de Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Interventions

Serum Bactericidal Test

Intervention Hierarchy (Ancestors)

Microbial Sensitivity Tests; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic

Study Officials

• Jules Audard

  CHU de Clermont-Ferrand

  STUDY CHAIR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; llaclautre_perrier@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double blind is not possible as this study evaluate a care strategy. However, in order to limit evaluation bias, the methodologist will be blinded to the group.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, controlled, multicenter, stepped wedge cluster randomized trial, considering centers as clusters.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: March 14, 2023
• Primary Completion: March 23, 2026
• Study Completion: March 23, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

FR (9)