Ultrasound Assessment of the Thickening Fraction of the Respiratory Muscles for Predicting Weaning Outcomes

NCT06724302 | Not Yet Recruiting

• 1 other identifier: 36265MD308/11/24
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The accuracy of ultrasound assessment of the thickening fraction of the diaphragm, parasternal intercostal, and abdominal expiratory muscles for predicting weaning outcomes in mechanically ventilated patients. A prospective observational study

Conditions

Weaning From Mechanical Ventilation

Keywords

diaghragm; Parasternal intercostal; Abdominal expiratory

Outcome Measures

Primary Outcomes (1)

• determine the accuracy of the thickening fraction of the diaphragm, parasternal muscles and abdominal expiratory muscles in predicting weaning outcome.

  Thickness of muscle during inspiration/thickness of muscle during expiration

  2 years

Secondary Outcomes (1)

• 1. Cut-off values of the thickening fraction of the diaphragm, parasternal intercostal, and abdominal expiratory muscles to predict weaning outcomes.

  2 years

Eligibility Criteria

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

Study Population

Patients will be enrolled if they are ≥18 years old, on invasive mechanical ventilation (MV) for more than 48 h and are eligible for first spontaneous breathing trial (SBT)

You may qualify if:

• Patients will be enrolled if they are ≥18 years old, on invasive mechanical ventilation (MV) for more than 48 h and are eligible for first spontaneous breathing trial (SBT) after fulfilling all the following criteria:
• Resolution or improvement of the disease leading to MV.
• Adequate oxygenation, indicated by arterial oxygen partial pressure to inspired oxygen fraction (PaO2/FiO2) ≥ 200 mmHg, both with positive end-expiratory pressure (PEEP) ≤ 5 cmH2O and rapid shallow breathing index\< 105.
• Adequate pulmonary function, indicated by a RR\<30 breaths/min with VT ≥5 mL/kg ideal body weight (IBW) and no significant respiratory acidosis with normal serum electrolytes.
• Stable hemodynamics status, without or with minimal vasopressors
• Conscious and cooperative patient
• Absence of excessive tracheobronchial secretion (\<3 times suction in the past 8 hours).

You may not qualify if:

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• Pregnancy.
• Presence of tracheostomy, pleural effusion, pneumothorax, pneumomediastinum, or hemothorax.
• Presence of rib fractures.
• Pre-existing cervical spinal injury, history or final diagnosis of neuromuscular disorders, and diaphragmatic paralysis or disorders
• Use of neuromuscular blocking agents within 48 hours.
• A distorted abdominal wall anatomy, or damage to the abdominal wall.
• Patients with localized fluid collections in the abdomen, hernias, abdominal wall hematomas, inguinal masses, femoral hernias, abdominal surgeries.
• BMI≥ 40
• Patients with previously failed SBT

Sponsors & Collaborators

• Tanta University: lead

Related Publications (1)

• DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

  PMID: 24365607 BACKGROUND

Central Study Contacts

Amer Soliman

CONTACT

+201094963127; amer.soliman0@gmail.com

Study Design

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

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share