Effect of a Personalized Weaning Strategy on Weaning Success

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Bordeaux
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU de Grenoble
RECRUITING
Grenoble
CHU de Lille
RECRUITING
Lille
CHU de Lyon - Hôpital Lyon Sud
RECRUITING
Lyon
CHU de Montpellier
RECRUITING
Montpellier
CHU de Nantes
RECRUITING
Nantes
CHU de Saint-Etienne
RECRUITING
Saint-etienne
CHU de Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Lise Laclautre
llaclautre_perrier@chu-clermontferrand.fr
+33473754963
Time Frame
Start Date: 2023-03-14
Estimated Completion Date: 2026-03-23
Participants
Target number of participants: 750
Treatments
Active_comparator: Standard intervention
Experimental: Personalized intervention - WIPO risk factors vs no risk factors
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov