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

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554095
• Other study ID #: Multimodal Weaning
• Status: Recruiting
• Start date: April 4, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Tracheostomy patients.

• Patients with neurological pathology with involvement of the brainstem.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Weaning Failure

Intervention

Other:
• Clinical data collection
Respiratory parameters, analytic values, lung ultrasound and echocardiography

Locations

Country	Name	City	State
Spain	Candelaria De Haro	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Predictive value of patient-ventilator interaction	association between asynchronies and weaning failure	From day 1 of mechanical ventilation until 48 hours after mechanical ventilation withdrawal