Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT04644458
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2020-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Ulna Length to Predict Tidal Volume in Adult Egyptians
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2020-11-15', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protective lung tidal volume', 'timeFrame': 'measurement of left ulna while standing for each volunteer throught the study completion, average 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tidal Volume']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height.', 'detailedDescription': 'After approval of local ethical committee and informed consent, one hundred healthy volunteers will be rnrolled in this study. Height of each subject will be measured while standing upright against a wall. Then, the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. From ulna length, height is estimated as advised by Malnutrition Advisory Group, British Association of Parenteral and Enteral Nutrition. October 2008. Malnutrition Universal Screening Tool.Protective lung tidal volume is calculated as 6 ml/kg predicted body weight (PBW) as follow:\n\nPBW= 50\\*0.91 (centimetres of height - 152.4) in males and 45.5\\*0.91(centimetres of height - 152.4) in females.\n\nEach measurement will be performed only once for each subject. Agreement between measurements will be expressed by the Bland-Altman method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Egyptian volunteers', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy adult Egyptian\n\nExclusion Criteria:\n\n\\- Deformity or previous surgery in the left arm'}, 'identificationModule': {'nctId': 'NCT04644458', 'briefTitle': 'Use of Ulna Length to Predict Tidal Volume in Adult Egyptians', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Use of Ulna Length to Predict Protective Lung Tidal Volume in Adult Egyptians', 'orgStudyIdInfo': {'id': '1990'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measuring the ulna length using meauring tape', 'type': 'OTHER', 'description': 'the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Bahaa M Refaie, MD', 'role': 'CONTACT'}], 'facility': 'Sohag university hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Bahaa M Refaie, MD', 'role': 'CONTACT', 'email': 'bahaarefaay@med.sohag.edu.eg', 'phone': '01026887257'}], 'overallOfficials': [{'name': 'Hosam eldeen M Marie, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Consultant of anesthesia and ICU Elhelal insurance hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and ICU', 'investigatorFullName': 'Bahaa Mohammed Refaie', 'investigatorAffiliation': 'Sohag University'}}}}