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Prediction of Outcome of Non Invasive Ventilation COPD Patients by Assessment of Diaphragmatic Performance

Can Transthoracic Ultrasound Assessment of the Diaphragmatic Performance Predict the Outcome of Non Invasive Ventilation in Critically Ill COPD Patients With Acute Exacerbation

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06143150
Enrollment
155
Registered
2023-11-22
Start date
2023-11-15
Completion date
2027-12-15
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation COPD

Brief summary

Transthoracic ultrasonographic assessment of the diaphragmatic performance as a predictor for the outcome of NIV in critically ill COPD patients with acute exacerbation.

Detailed description

Chronic obstructive pulmonary disease (COPD) is considered a common disease worldwide, and it poses a major health and economic problem. COPD was the fifth leading cause for death in 2022 and will rank third by 2030. So, it's considered a devastating disease for patients and their loved ones . Patients presented with acute exacerbations of COPD may need respiratory intensive care unit (RICU) admission. Non invasive ventilation (NIV) is considered a cornerstone management option in patients with acute exacerbation of COPD (AECOPD). Therefore, early prediction of NIV failure may help in decision making regarding escalation to invasive mechanical ventilation To date, the diaphragm is the main respiratory muscle, and derangement of it's function is an important factor in the pathophysiology of COPD COPD patients have increased airway resistance and airflow limitation, which in turn increases the mechanical load of breathing exerted on the diaphragm Diaphragmatic weakness in COPD patients results from decreased muscle strength and mobility . Although, diaphragmatic performance is a key determinant of dyspnea in COPD patients, it is rarely assessed in clinical practice In practice, only vital sign such as respiratory rate and arterial blood gases parameters (ABG) such as PH, PaO2, PaCO2, SPO2, and fiO2/paO2 are considered predictors of NIV outcome. Assessment of diaphragmatic function transthoracic ultrasound (TUS) is a reliable, safe and bed side method for prediction of NIV outcome . Several tools commonly applied to determine diaphragmatic function such as; fluoroscopy, Computed tomography (CT), transdiaphragmatic pressure measurement, phrenic nerve stimulation, and electromyography can't be routinely used in intensive care units due to technical challenges and limitations

Interventions

The following parameters will be assessed by TUS: Diaphragmatic copulae position and mobility (inspiratory time, excursion, diaphragmatic thickening fraction TF , excursion time E-T index )

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* One Hundred fifty five critically ill COPD patients admitted to respiratory intensive care unit * Diagnosis of COPD and COPD exacerbation is fulfilled according to GOLD 2022 criteria * Age\>40years

Exclusion criteria

* Age ˂ 40 years. * Refusal to participate in the study. * Patients with morbid obesity (BMI\>40). * Absolute indication for intubation like coma ,hemodynamic instability, or life threatening arrhythmia. * Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy, or active upper gastrointestinal bleeding.

Design outcomes

Primary

MeasureTime frameDescription
ultrasonographic assessement of COPD patientsBaselineTo assess the diaphragmatic performance by transthoracic ultrasound in critically ill COPD patients with acute exacerbation

Secondary

MeasureTime frameDescription
Time savingBaselineTo estimate: * In hospital mortality. * Length of ICU stay. * Length of hospital stay.

Contacts

Primary ContactMona A. Mostafa, Master
maiadel9995@gmail.com01124629683

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026