Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 2:52 AM
Study NCT ID:
NCT04012151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-09
First Post:
2019-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arm and Finger Measurement for Blood Pressure Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-10', 'size': 998030, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-16T01:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-07-04', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm length (Left, Right)', 'timeFrame': 'During antenatal visit (1-2 hours). One visit only', 'description': 'The distance (cm) between the tip of the acromion process to the tip of the olecranon process on the posterior aspect of the arm, with the elbow in the flexed position.'}, {'measure': 'Mid Arm circumference (MAC)(Left, Right)', 'timeFrame': 'During antenatal visit (1-2 hours). One visit only', 'description': 'The circumference (cm) of the arm at the mid-point of the arm length as measured above, with the arm hanging by the side.'}], 'secondaryOutcomes': [{'measure': 'Proximal arm circumference (Left, Right)', 'timeFrame': 'During antenatal visit (1-2 hours). One visit only', 'description': 'Arm circumference (cm) of the arm measured at the axilla, with the arm hanging by the side.'}, {'measure': 'Distal arm circumference (Left, Right)', 'timeFrame': 'During antenatal visit (1-2 hours). One visit only', 'description': 'The circumference (cm) at the elbow above the elbow crease, with the arm hanging by the side.'}, {'measure': 'Finger circumference (Left, Right)', 'timeFrame': 'During antenatal visit (1-2 hours). One visit only', 'description': 'The circumference (cm) of the mid-point of the middle phalanx of the middle finger will be measured with the hands placed flat on a table.'}, {'measure': 'Feedback on experiences of previous BP measurement', 'timeFrame': 'During antenatal visit (1-2 hours). One visit only', 'description': 'Participants will also respond to a three-point rating scale (Never, sometimes, always) about their experience of the procedures for previous BP measurement during the current pregnancy, with questions such as the length of time taken to obtain a reading, the need to change a cuff when taking BP, the need to take BP on the leg and whether the arm felt uncomfortable when taking blood pressure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood pressure measurement', 'Conicity index', 'Mid arm circumference', 'Cuff size'], 'conditions': ['Hypertension, Pregnancy-Induced']}, 'referencesModule': {'references': [{'pmid': '12714851', 'type': 'BACKGROUND', 'citation': "O'Brien E, Asmar R, Beilin L, Imai Y, Mallion JM, Mancia G, Mengden T, Myers M, Padfield P, Palatini P, Parati G, Pickering T, Redon J, Staessen J, Stergiou G, Verdecchia P; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement. J Hypertens. 2003 May;21(5):821-48. doi: 10.1097/00004872-200305000-00001. No abstract available."}, {'pmid': '15699287', 'type': 'BACKGROUND', 'citation': 'Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6.'}, {'pmid': '8222141', 'type': 'BACKGROUND', 'citation': 'Perloff D, Grim C, Flack J, Frohlich ED, Hill M, McDonald M, Morgenstern BZ. Human blood pressure determination by sphygmomanometry. Circulation. 1993 Nov;88(5 Pt 1):2460-70. doi: 10.1161/01.cir.88.5.2460. No abstract available.'}, {'pmid': '12044323', 'type': 'BACKGROUND', 'citation': 'Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. doi: 10.1081/PRG-100104165. No abstract available.'}, {'pmid': '1610779', 'type': 'BACKGROUND', 'citation': 'Penaz J. Criteria for set point estimation in the volume clamp method of blood pressure measurement. Physiol Res. 1992;41(1):5-10.'}, {'pmid': '21317721', 'type': 'RESULT', 'citation': 'Palatini P, Parati G. Blood pressure measurement in very obese patients: a challenging problem. J Hypertens. 2011 Mar;29(3):425-9. doi: 10.1097/HJH.0b013e3283435b65. No abstract available.'}, {'pmid': '12900586', 'type': 'RESULT', 'citation': "Fonseca-Reyes S, de Alba-Garcia JG, Parra-Carrillo JZ, Paczka-Zapata JA. Effect of standard cuff on blood pressure readings in patients with obese arms. How frequent are arms of a 'large circumference'? Blood Press Monit. 2003 Jun;8(3):101-6. doi: 10.1097/00126097-200306000-00002."}, {'pmid': '20686489', 'type': 'RESULT', 'citation': 'Bonso E, Saladini F, Zanier A, Benetti E, Dorigatti F, Palatini P. Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences. Hypertens Res. 2010 Nov;33(11):1186-91. doi: 10.1038/hr.2010.146. Epub 2010 Aug 5.'}, {'pmid': '22278143', 'type': 'RESULT', 'citation': 'Palatini P, Benetti E, Fania C, Malipiero G, Saladini F. Rectangular cuffs may overestimate blood pressure in individuals with large conical arms. J Hypertens. 2012 Mar;30(3):530-6. doi: 10.1097/HJH.0b013e32834f98a0.'}, {'pmid': '27582825', 'type': 'RESULT', 'citation': 'Kho CL, Brown MA, Ong SL, Mangos GJ. Blood pressure measurement in pregnancy: the effect of arm circumference and sphygmomanometer cuff size. Obstet Med. 2009 Sep;2(3):116-20. doi: 10.1258/om.2009.090017. Epub 2009 Sep 1.'}, {'pmid': '30527095', 'type': 'RESULT', 'citation': 'Eley VA, Roberts L, Rickards L, Pelecanos A, Blackie A, Zhang C, Christensen R, Barrett HL. Arm and finger measurements in the third trimester: Implications for blood pressure measurement. Pregnancy Hypertens. 2018 Oct;14:105-109. doi: 10.1016/j.preghy.2018.09.002. Epub 2018 Sep 5.'}, {'pmid': '8017333', 'type': 'RESULT', 'citation': 'Wang J, Thornton JC, Russell M, Burastero S, Heymsfield S, Pierson RN Jr. Asians have lower body mass index (BMI) but higher percent body fat than do whites: comparisons of anthropometric measurements. Am J Clin Nutr. 1994 Jul;60(1):23-8. doi: 10.1093/ajcn/60.1.23.'}, {'pmid': '32867679', 'type': 'DERIVED', 'citation': 'Lim MJ, Tan CW, Tan HS, Sultana R, Eley V, Sng BL. Correlation of patient characteristics with arm and finger measurements in Asian parturients: a preliminary study. BMC Anesthesiol. 2020 Aug 31;20(1):218. doi: 10.1186/s12871-020-01131-6.'}]}, 'descriptionModule': {'briefSummary': 'Accurate blood pressure (BP) measurement is critical in peripartum care. The cuff and bladder sizes affects the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC). However, evidence have shown the discrepancies between these sizes, leading to inaccuracy of BP measurement. This study will measure arm and finger size of 300 parturients in third trimester to determine whether the MAC, finger measurement or body mass index (BMI) is the best clinical predictor for non-standard cuff sizes for BP measurement.', 'detailedDescription': "Accurate blood pressure (BP) measurement plays an important role in peripartum care as it is essential in detecting hypertensive disorders in pregnancy and medical decision making during the pregnancy. The cuff and bladder size have been highlighted as an important factor affecting the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC) assuming the arm is cylindrical in shape. However, evidence have shown a mismatch between these sizes, leading to BP overestimation or underestimation in obese patients. This is because the shape of the arm is a truncated cone instead of a cylinder, and the cuff will expand irregularly during inflation thus yielding inaccurate BP measurements. This is especially evident in Asian pregnant patients whereby no available guideline can recommend a suitable cuff for parturients with different MAC. Nexfin is a finger cuff device that can be a suitable alternative BP measurement device for such patients. In this study 300 parturients will be recruited in third trimester and undergoing nonemergent caesarean section in KKH. Patients' arm and finger sizes will be measured, and their user experience on current practices on BP measurement. The arm measurements will help to identify the proportion of women that may require non-standard cuff sizes for BP measurement. A conicity index will be determined whether the MAC, finger measurement or BMI is the best clinical predictor. The finger measurements will also help to determine the proportion of women that may require non-standard cuff sizes on the Nexfin device for BP measurement. The knowledge gathered in this pilot study will be used to design future studies in which the accuracy of Nexfin will be compared with standard BP measurement, which in turn will improve BP detection, subsequent patient monitoring and satisfaction."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women in Singapore', 'genderDescription': 'Pregnant female in third trimester (\\>=32 weeks gestation)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anaesthesiologists physical status 1 or 2 (ASA 1 or 2) parturients at 32 or more weeks of gestation\n* Multiparous or nulliparous;\n* Age 21-50 years old;\n* Undergoing Caesarean section in our institution.\n\nExclusion Criteria:\n\n* Emergent Caesarean section such that consent and measurements cannot be taken.'}, 'identificationModule': {'nctId': 'NCT04012151', 'acronym': 'ARMFIN', 'briefTitle': 'Arm and Finger Measurement for Blood Pressure Surveillance', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Arm and Finger Measurement for Blood Pressure Surveillance', 'orgStudyIdInfo': {'id': 'ARMFIN'}, 'secondaryIdInfos': [{'id': 'ANAESPRG19/012', 'type': 'OTHER', 'domain': 'SingHealth ANAES ACP'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant cohort', 'description': 'Parturients of gestational age \\>= 32 weeks will have measurements of arm length, MAC, proximal arm circumference, distal arm circumference, finger circumference to generate the conicity index.', 'interventionNames': ['Other: Physical measurement', 'Other: Cuff size fitting']}], 'interventions': [{'name': 'Physical measurement', 'type': 'OTHER', 'otherNames': ['Measurement of fingers and arms'], 'description': 'Parturients of gestational week \\>= 32 weeks will have their arms and fingers measured to generate the conicity index.', 'armGroupLabels': ['Pregnant cohort']}, {'name': 'Cuff size fitting', 'type': 'OTHER', 'otherNames': ['Cuff fitting for arm and finger'], 'description': 'Fit on arm cuff and finger cuff as selected by investigators based on the measurement.', 'armGroupLabels': ['Pregnant cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Farida Ithnin, MMED (Anaes)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}