Development of a Multimodal Index to Improve the Predictive Value of Success in Weaning From Mechanical Ventilation

NCT04554095 | Recruiting

• 1 other identifier: Multimodal Weaning
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Weaning from mechanical ventilation (MV) is a complex process in which patients are liberated from the ventilator. Prolongued weaning and weaning failure, defined as the need for reintubation, have different adverse effects, including prolongation of MV, intensive care unit (ICU) and hospital stay, and are also associated with increased incidence of ventilator-associated pneumonia and high mortality. The rate of weaning failure is high, even when the classic extubation criteria are met, so it is necessary to improve scores that allow predicting and determining the ideal time for MV withdrawal. The aim of this study is to design a new multimodal index to predict and optimize weaning results in a personalized way, based on the use and interpretation of data derived from continuous monitoring of critically ill patients. The new multimodal index, in addition to classical respiratory parameters, will include parameters related to patient-ventilator interaction (asynchronies), diaphragmatic function, cardiovascular status and autonomic nervous system function (ANS). The investigators have designed a prospective observational study that will include 126 critical patients from a medical-surgical ICU that meet the classical criteria for weaning. The management of the patients, as well as the weaning process, will be carried out following the usual protocol. In addition to the classical weaning predictor data, data on the patient-ventilator interaction and the function of the autonomic nervous system will be collected by means of specific software (BetterCare). Cardiovascular and diaphragmatic function will be evaluated using ultrasound. Based on the advanced analysis of data from different devices collected throughout the mechanical ventilation period, it will be designed a "personalized" weaning score that should improve the accuracy of the decision-making process and therefore reduce morbidity and mortality. Additional benefits would include lowering health care costs without increasing adverse events.

Conditions

Weaning Failure; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• Multimodal index for weaning prediction evaluation

  Number of successful weanings evaluated through the new multi-modal index compared to the classic indexes

  48 hours after mechanical ventilation withdrawal

Secondary Outcomes (1)

• Predictive value of patient-ventilator interaction

  From day 1 of mechanical ventilation until 48 hours after mechanical ventilation withdrawal

Interventions

Clinical data collection OTHER

Respiratory parameters, analytic values, lung ultrasound and echocardiography

Eligibility Criteria

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

Study Population

Patients admitted to the ICU of the Parc Taulí Universitary Hospital undergoing MV and starting the weaning process according to the protocol established for usual clinical care practice.

You may qualify if:

• Patients with MV\> 24 hours.
• Patients with orotracheal tube.
• Patients who meet the classic criteria of weaning from the MV defined as:
• Improvement or resolution of the cause required for MV. PaO2\> 60mmHg with FiO2≤0.4 and PEEP ≤8cm H2O. Glasgow Coma Score\> 10 Temperature \<38 ° C. Hemoglobin\> 8g / dL No need for vasoactive drugs or at doses \<5μg / kg / min Obtaining informed consent.

You may not qualify if:

• Tracheostomy patients.
• Patients with neurological pathology with involvement of the brainstem.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Candelaria De Haro

Sabadell, Barcelona, 08208, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor and Doctor of Philosophy

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 18, 2020
• Study Start: April 4, 2022
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

ES (1)