Comparison of Weaning Parameters and Diaphragm Thickness Changes

NCT06967623 | Completed

• 2 other identifiers: 2022.111.06.01tarık durna
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Determining the appropriate timing for mechanical ventilator weaning in intensive care unit patients is critical to avoid complications related to early or late weaning, including weaning failure. Common predictors such as P0.1, F/VT, WOB, and P0.1 × F/VT are routinely used to guide this decision. Recently, diaphragm muscle weakness has been recognized as a significant contributor to weaning failure. Ultrasound has emerged as a useful, repeatable, and non-invasive tool for assessing diaphragmatic function. This study investigates the relationship between ultrasound-based diaphragm thickness changes and standard weaning predictors. It also evaluates the impact of demographic variables such as age, gender, weight, and comorbidities on diaphragm thickness. A total of 68 mechanically ventilated patients, aged 18 years or older, with Glasgow Coma Scale \>8 and BMI \<35, were included. Ultrasound measurements were performed on the first day of intubation and prior to extubation, using a high-frequency linear probe from the right anterior mid-axillary line at the 8th-10th rib level. Weaning was considered successful if patients maintained spontaneous breathing for 48 hours post-extubation.

Conditions

Mechanical Ventilation; Weaning Failure; Intensive Care Unit (ICU) Patients; Diaphragm Dysfunction

Keywords

Diaphragm ultrasonography; Mechanical ventilation; Diaphragm thickness; Weaning; Weaning parameters

Outcome Measures

Primary Outcomes (2)

• Change in Diaphragm Thickness

  The primary outcome of the study will be the change in diaphragm thickness, measured using ultrasound before and after extubation.

  From Day 1 of mechanical ventilation to the day of planned extubation, up to 14 days

• Number of Participants with Successful Weaning (Maintaining Spontaneous Breathing for ≥48 Hours Post-Extubation)

  Weaning success will be defined as the patient's ability to maintain spontaneous breathing without the need for reintubation or mechanical ventilatory support for at least 48 hours following extubation. Participants who require reintubation or ventilatory assistance within 48 hours will be considered as weaning failures.

  Up to 48 hours after extubation

Study Arms (2)

weaning successful

Patients who can maintain spontaneous breathing for 48 hours

Device: diaphragm ultrasound

weaning failed

Patients who have failed spontaneous breathing attempts or require intubation within 48 hours after extubation

Device: diaphragm ultrasound

Interventions

diaphragm ultrasound DEVICE

On the day of hospitalization or the first day of mechanical ventilation, the patient's position was elevated by 30°, and the high-frequency linear probe of the ultrasound was placed perpendicular to the skin in the cranio-caudal direction, and the diaphragm apposition zone, where the right anterior and middle axillary line corresponds to the 8th-10th intercostal space, was imaged and measurements were made with B mode.

weaning failed; weaning successful

Eligibility Criteria

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

Study Population

The study will include 68 adult participants (18+ years) who are intubated and undergoing mechanical ventilation for at least 24 hours in an ICU. Inclusion Criteria: Intubated for 24+ hours, Glasgow Coma Scale (GCS) \> 8, BMI \< 35, meets weaning criteria, willing to consent. Exclusion Criteria: Age \< 18, severe cognitive or neurological impairment, ventilation \< 24 hours, severe comorbidities, pregnancy/breastfeeding, contraindications for diaphragm ultrasound. Population Characteristics: The cohort will consist of ICU patients being evaluated for weaning, representing a range of ages, genders, and comorbidities. Demographic and clinical data will be analyzed for correlations with diaphragm thickness change and weaning success. Study Design: An observational cohort study using ultrasound to assess diaphragm thickness in relation to mechanical ventilation weaning outcomes.

You may qualify if:

• Age: Participants aged 18 years or older.
• Intubation Status: Participants who are intubated and receiving mechanical ventilation for at least 24 hours.
• Glasgow Coma Scale (GCS): Participants with a GCS score of greater than 8 at the time of enrollment.
• Body Mass Index (BMI): Participants with a BMI lower than 35.
• Weaning Suitability: Participants who are being evaluated for weaning from mechanical ventilation based on routine ICU weaning parameters.
• Informed Consent: Participants or their legal representatives must provide informed consent to participate in the study.

You may not qualify if:

• Age: Participants younger than 18 years.
• Neurological or Cognitive Impairments: Participants with neurological or cognitive conditions that may affect the ability to participate in the study or give informed consent.
• Mechanical Ventilation Duration: Participants who have been on mechanical ventilation for less than 24 hours at the time of enrollment.
• Severe Respiratory Conditions: Participants with conditions such as acute respiratory distress syndrome (ARDS) or those requiring higher levels of respiratory support, such as invasive or non-invasive positive pressure ventilation.
• Severe Heart Failure: Participants with severe heart failure or other critical cardiovascular conditions that may interfere with the ability to tolerate weaning procedures.
• Pregnancy: Female participants who are pregnant or breastfeeding.
• Other Contraindications: Any participant for whom diaphragm ultrasound measurements would be technically difficult or clinically inappropriate (e.g., due to anatomical or technical factors).

Sponsors & Collaborators

• Tarık Durna: lead

Study Sites (1)

Namık Kemal University Hospital

Tekirdağ, 59020, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: May 13, 2025
• Study Start: July 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)