Diaphragm Training Ultrasound

DIAPHRAGM -Ultrasound -Weaning -Mechanical Ventilation Clinical Trial

— DiaphUS  

Official title:

Ultrasound Assessment of Diaphragmatic Muscle Exercise in Mechanically Ventilated Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04186325
• Other study ID #: diaphragm ultrasound
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: Maha Abozeid, MD
• Phone: 02-01019216192
• Email: mahazed[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Common neurological indications of intubation and initiation of mechanical ventilation (MV) include ischemic and hemorrhagic stroke, neurotrauma, and intracranial hemorrhage. Mechanical ventilation is frequently applied to protect the airway from the risk of aspiration and to prevent both hypoxemia and hypercapnia, which are two major systemic factors of secondary brain insult.

Mechanical ventilation after endotracheal intubation predisposes these patients to an increased incidence of pulmonary complications such as ventilator-associated pneumonia (VAP), increased risk of deep vein thrombosis, bedsores, increased hospital stay, and poor clinical outcome.

The weaning process from MV involves the reduction of ventilator parameters and Extubation. Daily, careful evaluation of clinical and neurological conditions and completion of spontaneous breathing trial (SBT) should be considered in order to recognize and facilitate the process of withdrawal of the MV.

The diaphragm which is the principal respiratory muscle provides nearly 75% of the resting pulmonary ventilation. However, In ICU patients, the diaphragm is vulnerable to damage from hypotension, hypoxia, and sepsis. Diaphragmatic dysfunction and atrophy is the main precipitating factor for difficult and successful weaning.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients attached to mechanical ventilation will be included in the study after the informed consent of the legal guardian.

Exclusion Criteria:

• Patients with severe acute lung injury, morbid obesity, chest wall deformity, direct diaphragmatic injury, cervical spine and patients who require neuromuscular infusion will be excluded from the study.

Related Conditions & MeSH terms

• DIAPHRAGM -Ultrasound -Weaning -Mechanical Ventilation

Intervention

Procedure:
• DIAPHRAGMATIC exercising
inspiratory muscle training (IMT) will be initiated starting from the first ICU day. IMT will be conducted for 10 minutes two sessions per day, with an initial load of 30% of the maximum inspiratory pressure (MIP) measured immediately after changing patients to pressure support mode, and increased up to 40% in the second 5 minutes if tolerated by the patient. In addition, these patients received the usual care of MV patients.

Locations

Country	Name	City	State
Egypt	Mansoura University-Emergency hospital-ICU	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of diaphragmatic muscle atrophy		seven mechanical ventilation days