Entropy Analysis and Complex Patient-ventilator Interactions During Mechanical Ventilation

NCT04128124 | Completed

• 1 other identifier: Tauli entropy-ICU
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Complex patterns of patient-ventilator interactions could be miscalculated by visual observation of mechanical ventilator screens or current algorithms based on physiologic waveforms to detect patient-ventilator asynchronies. Therefore, we aim to characterize, validate and study the clinical distribution and implications of an automated and personalized non-invasive tool based on Entropy to detect Complex Patient-Ventilator Interactions (CP-VI) during mechanical ventilation, defined as breathing pattern change and/or clusters of asynchronies, over the signals of airway pressure (Paw) and airway flow (Flow).

Conditions

Patient Ventilator Interactions; Spontaneous Breathing Trial

Keywords

asynchronies; mechanical ventilation; irregularity; complexity; breathing pattern; self-extubation; weaning

Outcome Measures

Primary Outcomes (2)

• validation of entropy to detect complex patient-ventilator interactions

  validation process of a the novel tool of entropy to detect properly complex patient-ventilator interactions compared to a group of experts physicians in mechanical ventilation

  3 months

• successful extubation (remaining free of mechanical ventilation 72 hours after extubation) in those patients with complex patient-ventilator interactions

  analizing the clinical course during the first week after extubation obtaining data from the medical chart and quantifier the distribution over time of complex patient-ventilator interactions detected by entropy.

  6 month

Secondary Outcomes (2)

• Rate of reintubation

  6 months

• Intensive care unit and hospital length of stay

  6 months

Study Arms (2)

self-extubation

patients receiving invasive mechanical ventilation who develops an episode of self-removal (voluntary) of the endotracheal tube. Excluding those accidentally removed.

Other: processing signals of airway pressure and airway flow to calculate entropy

spontaneous breathing trial

patients who, according to the attending physician, are clinically ready to initiate and begin a protocolized test (acording to the institutions or unit) to evaluate the readiness to be liberated from mechanical ventilation.

Other: processing signals of airway pressure and airway flow to calculate entropy

Interventions

processing signals of airway pressure and airway flow to calculate entropy OTHER

processing of previously recorded data from a dedicated software of airway pressure and airway flow in order to calculate entropy

self-extubation; spontaneous breathing trial

Eligibility Criteria

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

Study Population

Adults patients admitted to the Intensive Care Unit without exclusion criteria and who develop a self-extuation episode or a spontaneous breathing trial will be recruited.

You may qualify if:

• Admission to a ICU bed equipped with BetterCare software and intubated fo mechanical ventilation expected to last more than 24hs
• patients who develops a self-extubation episode or a spontaneous breathing trial.

You may not qualify if:

• \<18 years
• \<48hs of recorded data
• moribund state
• admission for organ donation
• chest tubes with suspected bronchopleural fistula
• accidental extubation

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Study Officials

• Lluis Blanch, M.D., Ph.D.

  Critical Care Center, Hospital Universitari Parc Tauli. Institut d'Investigació i Innovació Parc Taulí.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)