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

Acute Exacerbation COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143150
• Other study ID #: Diaphragmatic performance
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: December 15, 2027

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Mona A. Mostafa, Master
• Phone: 01124629683
• Email: maiadel9995[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 155
• Est. completion date: December 15, 2027
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Exacerbation COPD

Intervention

Other:
• transthoracic ultrasound
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 )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Ko FW, Chan KP, Hui DS, Goddard JR, Shaw JG, Reid DW, Yang IA. Acute exacerbation of COPD. Respirology. 2016 Oct;21(7):1152-65. doi: 10.1111/resp.12780. Epub 2016 Mar 30. — View Citation

Rittayamai N, Chuaychoo B, Tscheikuna J, Dres M, Goligher EC, Brochard L. Ultrasound Evaluation of Diaphragm Force Reserve in Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2020 Oct;17(10):1222-1230. doi: 10.1513/AnnalsATS.202002-129OC. — View Citation

Schulz A, Erbuth A, Boyko M, Vonderbank S, Gurleyen H, Gibis N, Bastian A. Comparison of Ultrasound Measurements for Diaphragmatic Mobility, Diaphragmatic Thickness, and Diaphragm Thickening Fraction with Each Other and with Lung Function in Patients with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2022 Sep 12;17:2217-2227. doi: 10.2147/COPD.S375956. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasonographic assessement of COPD patients	To assess the diaphragmatic performance by transthoracic ultrasound in critically ill COPD patients with acute exacerbation	Baseline
Secondary	Time saving	To estimate: In hospital mortality.; Length of ICU stay.; Length of hospital stay.	Baseline

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