Left Ventricular Diastolic Dysfunction as a Predictor of Weaning Failure From Mechanical Ventilation

NCT04703387 | Completed

• 1 other identifier: 33855/6/20
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Both premature and delayed extubation prolong the duration of mechanical ventilation and the intensive care unit (ICU) length of stay and increase morbidity and mortality. Therefore, accurate prediction of postextubation distress and the early diagnosis of the causes responsible for failure of a trial of pressure support ventilation are of paramount importance to improve the outcome of mechanically ventilated patients in the ICU. This observational study is designed to test the ability of cardiac and diaphragm function assessed by bedside ultrasound to predict extubation failure within 48 h and re-intubation within 1 week after extubation.

Conditions

Left Ventricular Diastolic Dysfunction; Weaning Failure; Mechanical Ventilation Complication; Diaphragmatic Disorder

Keywords

Mechanical Ventilation Complication; Left Ventricular Diastolic Dysfunction; Pulmonary Edema; echocardiography

Outcome Measures

Primary Outcomes (1)

• Weaning failure

  Weaning failure predicted by diastolic dysfunction assessed by E/Ea.

  within 48 hours after extubation

Secondary Outcomes (1)

• Weaning failure

  within 48 hours after extubation

Study Arms (2)

Postextubation Success

Diagnostic Test: transthoracic echocardiography

Postextubation Distress

Diagnostic Test: transthoracic echocardiography

Interventions

transthoracic echocardiography DIAGNOSTIC_TEST

Trans-mitral flow velocities (peak early diastolic E and peak late diastolic A) will be recorded with pulsed-wave Doppler, placing the sample volume at the mitral valve tips from the apical 4-chamber view; deceleration time of the E wave (DTE) will be measured. Peak early diastolic velocity will be obtained with tissue Doppler imaging (TDI), in the apical 4-chamber view, positioning the pulsed-wave Doppler sample volume at or 1 cm within the septal insertion sites of the mitral leaflets, so as to cover the longitudinal excursion of the mitral annulus in both systole and diastole. Then, the E/A ratio and the trans-mitral inflow E wave to mitral annular e' (E/e) will be calculated.Diaphragmatic thickness will be assessed in the zone of apposition of the diaphragm to the rib cage between the 8th and 10th intercostal spaces using a 3-12 MHz linear array probe , we will record changes in diaphragm vertical excursion using M-mode ultrasound.

Also known as: diaphragm ultrasonographic

Postextubation Distress; Postextubation Success

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients aged more than 40 years who are intubated and mechanically ventilated for more than 48 hours, with improvement of underlying cause of acute respiratory failure and considered ready to undergo a spontaneous breathing trial (SBT) by the attending physician on the basis of readiness-to-wean criteria used in our surgical ICUn Criteria

You may not qualify if:

• Planning for tracheostomy after the SBT.
• Severe mitral stenosis, severe regurgitation, or prosthetic mitral valve.
• History of diaphragmatic dysfunction as diaphragmatic palsy, cervical spine injury, or neuromuscular disease.
• Pneumothorax or pneumo-mediastinum.
• Use of muscle-paralyzing agents within 48 h before the study.
• Poor echocardiographic windows or difficult windows of diaphragmatic movement as women in late pregnancy or obese patients.
• Extubation failure definitely caused by upper airway obstruction.
• Planned prophylactic noninvasive ventilation (NIV) after extubation.
• Atrial fibrillation or atrioventricular conduction abnormality.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Pulmonary Edema

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: August 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

EG (1)