Use of Diaphragm Ultrasound and Evaluation of Respiratory Parameters in Determining Weaning Success in Geriatric Patients

Completed

• Conditions: Weaning Failure of Mechanical Ventilation; Diaphragm Ultrasonography; Geriatric

• Registration Number: NCT07044063
• Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital

Brief Summary

This study aims to evaluate the effectiveness of ultrasound-based diaphragmatic measurements in predicting weaning success in patients aged 65 and older who are receiving mechanical ventilation. Additionally, it seeks to contribute to the clinical decision-making process by examining the relationship between these measurements and conventional weaning parameters.

Detailed Description

Weaning refers to the gradual reduction of mechanical ventilatory support. Approximately 40% of the time patients spend on mechanical ventilation is dedicated to the weaning process. Patients who fail the spontaneous breathing trial (SBT) or require reintubation within 48 hours after extubation are considered to have experienced weaning failure. Around 20-30% of patients receiving invasive mechanical ventilation are classified as difficult to wean.

In the geriatric population, the weaning process becomes even more challenging due to age-related changes such as decreased lung elasticity, reduced muscle mass, and diminished lung volumes. Although various scales have been developed to predict weaning success, their correlation with actual clinical outcomes remains uncertain.

The diaphragm is the primary muscle involved in active inspiration. Dysfunction of the diaphragm can lead to impaired cough reflex and respiratory failure. In recent years, ultrasonography (US) has been used to assess diaphragmatic thickness and movement through the right hemithorax during inspiration and expiration. From these measurements, parameters such as Diaphragm Thickness during inspiration and expiration (DTi and DTe), Diaphragm Thickening Fraction (DTF), and Diaphragm Excursion (DE) can be calculated. Several studies have investigated the association between these parameters and weaning success.

In this planned study, the investigators aim to evaluate the predictive value of ultrasound-derived diaphragmatic parameters (DTi, DTe, DTF, and DE) for weaning success in geriatric patients who are intubated and monitored in intensive care units. Additionally, investigators intend to assess the correlation between these parameters and other respiratory indicators.

The primary objective of this study is to examine the relationship between diaphragmatic parameters measured via ultrasonography within 24 hours prior to weaning and weaning outcomes in intubated ICU patients aged 65 years and older. The secondary objective is to compare the correlation of these parameters with other conventional respiratory parameters.

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 65 years and older
• Admitted to ICU
• Intubated and mechanically ventilated for at least 24 hours
• Clinically decided to wean from mechanical ventilation

Exclusion Criteria

• Those who have mechanically ventilated for more than 14 days
• Those who have been tracheostomized
• Those with preexisting diaphragm or lung pathologies
• Those who had cardiothoracic surgery
• Those with muscular or musculoskeletal diseases
• Those with Glasgow Coma Scale lower than 10T without sedation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm Thickness Measurement	Within 24 hours prior to weaning from mechanical ventilation.	Diaphragm thicknesses are measured with linear ultrasound probe at 8-10th intercostal space on anterior or middle axillary line using B-mode during inspiration and expiration.
Diaphragmatic Excursion Measurement	Within 24 hours prior to weaning from mechanical ventilation.	Diaphragmatic excursion is measured with convex probe at midclavicular line just below costal arch using M-mode during respiratory cycle.
Diaphragm Thickening Fraction	Within 24 hours prior to weaning from mechanical ventilation.	Diaphragmatic thickening fraction is calculated by taking the difference between diaphragm thickness at end-inspiration and diaphragm thickness at end-expiration, dividing it by the thickness at end-expiration, and multiplying by 100 to get a percentage.

Secondary Outcome Measures

Name	Time	Method
PaO2/FiO2 (mmHg)	Within 24 hours prior to weaning from mechanical ventilation.	PaO2 from arterial blood gas analysis was divided by fractional inspired oxygen to calculate this value.
Arterial Blood Gas	Within 24 hours prior to weaning from mechanical ventilation.	pH, Partial Pressure of Carbon Dioxide (mmHg) , Partial Pressure of Oxygen (mmHg), Oxygen Saturation(SaO2) values from arterial blood gas will be collected.
Oxygen Saturation	Within 24 hours prior to weaning from mechanical ventilation	Peripheral Oxygen Saturation Percentage
Respiratory Rate (Breaths per Minute)	Within 24 hours prior to weaning from mechanical ventilation	Respiratory rate per minute will be collected.
Rapid Shallow Breathing Index (Breath/Minute/L)	Within 24 hours prior to weaning from mechanical ventilation	RSBI will be calculated by dividing respiratory rate per minute to tidal volume in liters.
Mechanical Ventilation Duration (Hours)	Within 24 hours prior to weaning from mechanical ventilation	Mechanical ventilation duration prior to the weaning trial of the patients was recorded in hours.
Tidal Volume and Minute Ventilation (L)	Within 24 hours prior to weaning from mechanical ventilation.	These values were collected from mechanical ventilator.
P0.1 (cmH2O)	Within 24 hours prior to weaning from mechanical ventilation.	P0. 1 is the negative airway pressure generated by the patient during the first 0.1 s against an occluded airway. P0. 1 can be obtained non-invasively in most new generation mechanical ventilators through a simple maneuver.
Dynamic Compliance (mL/cmH2O)	Within 24 hours prior to weaning from mechanical ventilation.	Dynamic compliance is measured by dividing the tidal volume, the average volume of air in one breath cycle, by the difference between the pressure of the lungs at full inspiration and full expiration. These values were collected from mechanical ventilator.

Trial Locations

Locations (1)

University of Health Sciences Kartal Dr. Lutfi Kirdar City Hospital; 🇹🇷 Istanbul, Turkey