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

• ClinicalTrials.gov Identifier: NCT04554095
• Recruitment Status: Not yet recruiting
• First Posted: September 18, 2020
• Last Update Posted: February 23, 2022
• Sponsor: Corporacion Parc Tauli
• Information provided by (Responsible Party): Candelaria de Haro, Corporacion Parc Tauli

Study Description

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.

Condition or disease	Intervention/treatment
Weaning Failure; Mechanical Ventilation Complication	Other: Clinical data collection

Study Design

• Study Type: Observational
• Estimated Enrollment: 126 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Development of a Multimodal Index to Improve the Predictive Value of Success in Weaning From Mechanical Ventilation
• Estimated Study Start Date: April 1, 2022
• Estimated Primary Completion Date: October 1, 2022
• Estimated Study Completion Date: December 1, 2022

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Multimodal index for weaning prediction evaluation [ Time Frame: 48 hours after mechanical ventilation withdrawal ]
   Number of successful weanings evaluated through the new multi-modal index compared to the classic indexes

Secondary Outcome Measures :

1. Predictive value of patient-ventilator interaction [ Time Frame: From day 1 of mechanical ventilation until 48 hours after mechanical ventilation withdrawal ]
   association between asynchronies and weaning failure

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Candelaria de Haro, Medical doctor and Doctor of Philosophy, Corporacion Parc Tauli
• ClinicalTrials.gov Identifier: NCT04554095
• Other Study ID Numbers: Multimodal Weaning
• First Posted: September 18, 2020
• Last Update Posted: February 23, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No