Diastolic dYsfunctioN AssessMent in critICally Ill Patients

NCT04584203 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 297

Last updated 2022-01-03

No results posted yet for this study

Summary

The role of the left ventricular diastolic function (LVDD) in the weaning failure from mechanical ventilation in unclear. Specifically, is unclear whether the outcome of the weaning process could be affected by a pre-existing LVDD (before ICU admission), or by the worsening of a chronic pattern, or by a de-novo LVDD presentation.

Conditions

  • Critical Illness
  • Diastolic Dysfunction
  • Diastolic Heart Failure
  • Weaning Failure
  • Mechanical Ventilation Complication

Interventions

DIAGNOSTIC_TEST

Bedside Echocardiography

All the intensivists performing the TTE in the involved centers fulfill the criteria of the American Society of Echocardiography and of the European Society of Intensive Care. Medicine to be considered as experts in critical care echocardiography. Each center performs the TTE evaluation by means of the ultrasound device available in the unit equipped with the tissue Doppler imaging program and a phased array transducer of 2.5 MHz and doppler signals is recorded along with the electrocardiogram. For the purpose of this study, the following TTE parameters are recorded from the apical 4-chamber view during each set of measurements:

PROCEDURE

Spontaneuos breathing trial

The Spontaneous Breathing Trial will be performed accordingly to the clinical practice of the involved centers (a total support - including positive end-expiratory pressure plus pressure support equal or lower to 8 cmH20)

DIAGNOSTIC_TEST

Bedside Echocardiography_1

Echocardiography performed within 24h from patient's admission - not optional

DIAGNOSTIC_TEST

Bedside Echocardiography_2

Echocardiography performed within 12h from patient's spontaneous breathing trial - not optional

DIAGNOSTIC_TEST

Bedside Echocardiography_3

Echocardiography performed at 60 +/- 12h from patient's admission - optional

DIAGNOSTIC_TEST

Bedside Echocardiography_4

Echocardiography performed 24h after patient's estubation - optional

Sponsors & Collaborators

  • Humanitas Clinical and Research Center

    lead OTHER

Principal Investigators

  • Antonio Messina, PhD · Humanitas Mirasole SpA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584203 on ClinicalTrials.gov