Study of Diaphragmatic Ultrasound as a Predictor of Mechanical Ventilation in Patients With Respiratory Diseases on Admission to Intensive Care Unit

NCT06254417 | Not Yet Recruiting

• 1 other identifier: master ICU
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ultrasonography has been used to explore diaphragmatic contractile activity by measuring thickening fraction .When thickening fraction was \< 20% during tidal breathing, it is commonly associated with respiratory failure. Diaphragmatic ultrasound had been used before as a tool to predict weaning from mechanical ventilation. In this study diaphragmatic ultrasound will be done upon admission to predict of mechanical ventilation in patients with respiratory diseases.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• estimation of diaphragmatic thickening fraction

  immediately after intensive care admission

Secondary Outcomes (1)

• estimation of diaphragmatic excursion

  immediately after intensive care admission

Study Arms (2)

NON VENTILATED GROUP

ACTIVE COMPARATOR

Procedure: Diaphragmatic ultrasound

VENTILATED GROUP

ACTIVE COMPARATOR

Procedure: Diaphragmatic ultrasound

Interventions

Diaphragmatic ultrasound PROCEDURE

Diaphragmatic ultrasound will be performed to all patients with respiratory disease to evaluate diaphragmatic thickening and estimate thickening fraction and to evaluate diaphragmatic excursion. Measurements will be obtained at bedside with a portable ultrasound machine equipped with a linear probe (Logic P6 Pro, GE Healthcare). Diaphragmatic thickness measures will be performed on right Intercostal approach through the zone of apposition. Diaphragmatic excursion will be performed using curved-array probe (Logic P6 Pro, GE Healthcare) is positioned below right costal arch at the mid-clavicular line. The ultrasound study will be done and /or supervised by ultrasound expert

NON VENTILATED GROUP; VENTILATED GROUP

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dyspnea: respiratory rate \> 22 breaths per min.
• Hypoxia: as SO2 \< 92% on room air.
• Hypercapnia: as PaCO2 \> 45mmHg.

You may not qualify if:

• Age \<18 year.
• Cardiogenic pulmonary edema.
• History of interstitial lung disease (fibrosis).
• Neuromuscular disease.
• Significant chest wall deformities.
• Previous diagnosis of diaphragmatic palsy.
• Recent thoracotomy or sternotomy (within the previous year).
• Severe hemodynamic instability or shock.
• Pregnancy.
• Diagnosis of pneumothorax or pneumo mediastinum.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 12, 2024
• Study Start: February 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02