Effect of a Personalized Weaning Strategy on Weaning Success

Mechanical Ventilation Clinical Trial

— P-Wean  

Official title:

Effect of a Personalized Weaning Strategy on Weaning Success

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719194
• Other study ID #: P-Wean PHRC IR 2020 AUDARD
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: March 16, 2025

Study information

• Verified date: June 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: +33473754963
• Email: llaclautre_perrier[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, cardiopathy) improves weaning success compared with usual practice.

Description:

Before the study begin, all participating centers will be randomized to determine the time between the control and the interventional period. Patients included in the study will not be randomized individually but will be managed either according to the standard of care of the service or according to the personalized strategy (according to the stepped wedge group of the center).

• Control period: Patients will be subjected to a weaning strategy in accordance with the usual care practices of the service (evaluation of the criteria of weanability, the modalities of the spontaneous breathing trial and extubation)

• Interventional period: Patients will undergo a protocolized and standardized weaning strategy, including a daily assessment of weaning criteria, and a weaning trial (PSV or T-piece) whose modalities will be defined by the presence or the absence of weaning induced pulmonary oedema risk factors. These are :

• Obesity defined as BMI >30 kg/m2

• Suspected or known COPD

• Heart disease whether it is structural (hypertrophic, dilated, valvular), functional (diastolic or systolic dysfunction), ischemic, or dysrhythmic.

Step 1 :

Daily assessment of weaning criteria in accordance with the study protocol

Step 2 :

• No risk factors : spontaneous breathing trial for 1 hour with pressure support ventilation (setting a pressure support level of 5 to 8 cm of water with no PEEP)

• Risk factors : spontaneous breathing trial with a T-piece for 1 hour, measuring protein and hemoglobin by blood sample before and after the trial. If it increase by more then 5% then it signs a weaning induced pulmonary oedema.

Step 3 : Reconnecting the patient for 1h and extubation if it was a success. If not, the optimization of cardiac function or fluid overload will be the responsibility of the clinician.

Decisions regarding the use of non-invasive ventilation (NIV) or high-flow nasal oxygenation, will be made based on each center's expertise and current clinical practice to minimize interference with the study procedure. However, knowing the recent data and the possible superiority of NIV in preventing post-extubation respiratory failure for high risk patients, investigators will be strongly encouraged to prioritize the prophylactic use of NIV (over high-flow nasal oxygenation) after tracheal extubation.

Patients will be assessed by members of the investigating center's research team (under the supervision of the center's investigators) at least daily during hospitalization in the ICU and until day 28 post-randomization, as well as at discharge and at 90 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 16, 2025
• Est. primary completion date: January 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria : all patients = 18 y.o admitted to the ICU, under invasive mechanical ventilation for more then 24 hours and fullfilling the following weaning criteria :

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Intubation
• Mechanical Ventilation
• Weaning

Intervention

Other:
• Standard SBT
Weaning strategy in accordance with the care practices of the department, regarding the assessment of weaning criteria, SBT and extubation modalities.
• 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 1 hour 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 1 hour and then extubate if SBT is successful.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU de Grenoble	Grenoble
France	CHU de Lille	Lille
France	CHU de Lyon - Hôpital Lyon Sud	Lyon
France	CHU de Montpellier	Montpellier
France	CHU de Nantes	Nantes
France	CHU de Saint-Etienne	Saint-Étienne
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of tracheostomy during the ICU stay.		28 days
Other	Incidence of non-invasive ventilation or high-flow nasal oxygenation post-extubation, both prophylactic and curative.		72 hours after extubation.
Other	Incidence of use for diuretics or beta-blockers for failed weaning trials or WIPO.		28 days
Other	Incidence of the absence of extubation despite a successful SBT.		28 days
Other	Time and reason for reintubation in case of failed extubation.		28 days
Primary	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	Rate of extubation success after the first SBT.		72 hours from first SBT
Secondary	Rate of reintubation		72 hours from first SBT
Secondary	Rate of reintubation		72 hours from extubation
Secondary	Reintubation rate within 7 days of extubation.		7 days after extubation
Secondary	Time from first SBT to extubation.		28 days
Secondary	SBT failure rate	Defined by respiratory rate increase of 50% or > 35/min, dyspnea, SpO2 < 88% or decrease of 5%, heart rate increase > 20%, systolic blood pressure increase > 20%, agitation, sweating.	28 days
Secondary	Number of days without mechanical ventilation		From day one of first SBT to day 28
Secondary	Length of stay in the ICU and in the hospital.		90 days
Secondary	Mortality of ICU stay/hospital stay.		90 days
Secondary	Mortality at day 28.		28 days
Secondary	Mortality at day 90.		90 days