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

NCT06143150 | Not Yet Recruiting

• 1 other identifier: Diaphragmatic performance
• Study Type: observational
• Target: 155
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Exacerbation COPD

Outcome Measures

Primary Outcomes (1)

• ultrasonographic assessement of COPD patients

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

  Baseline

Secondary Outcomes (1)

• Time saving

  Baseline

Interventions

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 )

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients admitted to respiratory intensive care unit with acute exacerbation

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 27028990 BACKGROUND

• 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.

  PMID: 32614240 BACKGROUND

• 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.

  PMID: 36118281 BACKGROUND

Related Links

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Central Study Contacts

Mona A. Mostafa, Master

CONTACT

01124629683; maiadel9995@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 22, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 15, 2027
• Last Updated: November 22, 2023

Record last verified: 2023-11