Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 6:26 AM
Study NCT ID:
NCT06143150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Outcome of Non Invasive Ventilation COPD Patients by Assessment of Diaphragmatic Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasonographic assessement of COPD patients', 'timeFrame': 'Baseline', 'description': 'To assess the diaphragmatic performance by transthoracic ultrasound in critically ill COPD patients with acute exacerbation'}], 'secondaryOutcomes': [{'measure': 'Time saving', 'timeFrame': 'Baseline', 'description': 'To estimate:\n\n* In hospital mortality.\n* Length of ICU stay.\n* Length of hospital stay.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Exacerbation COPD']}, 'referencesModule': {'references': [{'pmid': '27028990', 'type': 'BACKGROUND', 'citation': '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': '32614240', 'type': 'BACKGROUND', '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.'}, {'pmid': '36118281', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8121160/', 'label': 'Related Info'}, {'url': 'https://ejmr.journals.ekb.eg/article_263842.html', 'label': 'Related Info'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4147838/', 'label': 'Related Info'}, {'url': 'https://ejb.springeropen.com/articles/10.4103/ejb.ejb_99_17', 'label': 'Related Info'}, {'url': 'https://ouci.dntb.gov.ua/en/works/l1wn5Py7/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Transthoracic ultrasonographic assessment of the diaphragmatic performance as a predictor for the outcome of NIV in critically ill COPD patients with acute exacerbation.', 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) is considered a common disease worldwide, and it poses a major health and economic problem.\n\nCOPD 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 .\n\nPatients 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.\n\nAssessment 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients admitted to respiratory intensive care unit with acute exacerbation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* One Hundred fifty five critically ill COPD patients admitted to respiratory intensive care unit\n* Diagnosis of COPD and COPD exacerbation is fulfilled according to GOLD 2022 criteria\n* Age\\>40years\n\nExclusion Criteria:\n\n* Age ˂ 40 years.\n* Refusal to participate in the study.\n* Patients with morbid obesity (BMI\\>40).\n* Absolute indication for intubation like coma ,hemodynamic instability, or life threatening arrhythmia.\n* Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy, or active upper gastrointestinal bleeding.'}, 'identificationModule': {'nctId': 'NCT06143150', 'briefTitle': 'Prediction of Outcome of Non Invasive Ventilation COPD Patients by Assessment of Diaphragmatic Performance', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Can Transthoracic Ultrasound Assessment of the Diaphragmatic Performance Predict the Outcome of Non Invasive Ventilation in Critically Ill COPD Patients With Acute Exacerbation', 'orgStudyIdInfo': {'id': 'Diaphragmatic performance'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transthoracic ultrasound', 'type': 'OTHER', 'description': 'The following parameters will be assessed by TUS:\n\nDiaphragmatic copulae position and mobility (inspiratory time, excursion, diaphragmatic thickening fraction TF , excursion time E-T index )'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mona A. Mostafa, Master', 'role': 'CONTACT', 'email': 'maiadel9995@gmail.com', 'phone': '01124629683'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mona Adel', 'investigatorAffiliation': 'Assiut University'}}}}