NCT07044063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
Last Updated

June 29, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 9, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

diaphragmultrasoundgeriatricweaningmechanical ventilation

Outcome Measures

Primary Outcomes (3)

  • Diaphragm Thickness Measurement

    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.

    Within 24 hours prior to weaning from mechanical ventilation.

  • Diaphragmatic Excursion Measurement

    Diaphragmatic excursion is measured with convex probe at midclavicular line just below costal arch using M-mode during respiratory cycle.

    Within 24 hours prior to weaning from mechanical ventilation.

  • Diaphragm Thickening Fraction

    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.

    Within 24 hours prior to weaning from mechanical ventilation.

Secondary Outcomes (9)

  • Arterial Blood Gas

    Within 24 hours prior to weaning from mechanical ventilation.

  • Oxygen Saturation

    Within 24 hours prior to weaning from mechanical ventilation

  • Respiratory Rate (Breaths per Minute)

    Within 24 hours prior to weaning from mechanical ventilation

  • Rapid Shallow Breathing Index (Breath/Minute/L)

    Within 24 hours prior to weaning from mechanical ventilation

  • Mechanical Ventilation Duration (Hours)

    Within 24 hours prior to weaning from mechanical ventilation

  • +4 more secondary outcomes

Study Arms (2)

Weaning Success Group

Patients who are weaned from mechanical ventilation within 24 hours of diaphragmatic ultrasound measurements and didn't need mechanical ventilation again for at least 48 hours was placed in this group.

Weaning Failure Group

Patients who are weaned from mechanical ventilation within 24 hours of diaphragmatic ultrasound measurements but needed mechanical ventilation support again within 48 hours after weaning was placed in this group.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the intensive care unit of Kartal Dr. Lutfi Kirdar Training and Research Hospital who are 65 years or older and underwent mechanical ventilation

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

April 9, 2025

First Posted

June 29, 2025

Study Start

December 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

June 29, 2025

Record last verified: 2025-04

Locations