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NCT Number: NCT06143150

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

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

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transthoracic ultrasound

Other

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 )

Primary outcomes

  1. ultrasonographic assessement of COPD patients

    Time frame: Baseline

    To assess the diaphragmatic performance by transthoracic ultrasound in critically ill COPD patients with acute exacerbation

Secondary outcomes

  1. Time saving

    Time frame: Baseline

    To estimate:

    • In hospital mortality.
    • Length of ICU stay.
    • Length of hospital stay.

Study contacts

Contact information is provided by the study sponsor or research team.

Mona A. Mostafa, Master

CONTACT

[email protected]

01124629683

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 22, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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