Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-29 @ 4:49 PM
Study NCT ID:
NCT05509335
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2022-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment On Effectiveness of Cricoid Pressure In Paediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-08-14', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of oesophagus compressible following application of CP in paediatric population', 'timeFrame': 'Through study completion, average 1 year', 'description': 'A published study quoted 45% lateral displacement of the oesophagus in younger children, the incidence was derived from a retrospective review of CT neck in children. Eccentric oesophagus has been associated with ineffective CP in adults. The investigators use ultrasound to determine the location of the oesophagus relative to the trachea. If the oesophagus is central, we assume CP is effective. On the other hand, if the oesophagus is eccentric, ultrasound would be used to assess the compressibility of the oesophagus following CP.'}], 'secondaryOutcomes': [{'measure': 'Determine incidence of eccentric oesophagus in paediatric population under effect of general anaesthesia', 'timeFrame': 'Through study completion, average 1 year', 'description': 'A published study was conducted from a retrospective review of CT cervical spine of children which found 45% eccentric oesophagus in younger children. However, the position was determined in awake patients with no effect of the anaesthetic drug. We like to investigate the effect of general anaesthetic agents (in particular muscle relaxant) on oesophagus position.'}, {'measure': 'Determine incidence of lateral displacement of oesophagus during CP', 'timeFrame': 'Through study completion, average 1 year', 'description': 'From our pilot study on 10 children aged \\< 8 years old, we observed centrally located oesophagus was displaced following the application of CP. We would like to investigate the incidence of this phenomenon and if there is a shift of oesophageal position, would the application of CP be effective in occluding the oesophagus.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cricoid pressure', 'oesophagus position', 'pediatric'], 'conditions': ['Aspiration of Food', 'Pediatric ALL']}, 'referencesModule': {'references': [{'pmid': '20881908', 'type': 'BACKGROUND', 'citation': 'Dotson K, Kiger J, Carpenter C, Lewis M, Hill J, Raney L, Losek JD. Alignment of cricoid cartilage and esophagus and its potential influence on the effectiveness of Sellick maneuver in children. Pediatr Emerg Care. 2010 Oct;26(10):722-5. doi: 10.1097/PEC.0b013e3181f39b74.'}, {'pmid': '27523050', 'type': 'BACKGROUND', 'citation': "Andruszkiewicz P, Wojtczak J, Wroblewski L, Kaczor M, Sobczyk D, Kowalik I. Ultrasound evaluation of the impact of cricoid pressure versus novel 'paralaryngeal pressure' on anteroposterior oesophageal diameter. Anaesthesia. 2016 Sep;71(9):1024-9. doi: 10.1111/anae.13518."}, {'pmid': '30347104', 'type': 'BACKGROUND', 'citation': 'Birenbaum A, Hajage D, Roche S, Ntouba A, Eurin M, Cuvillon P, Rohn A, Compere V, Benhamou D, Biais M, Menut R, Benachi S, Lenfant F, Riou B; IRIS Investigators Group. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. doi: 10.1001/jamasurg.2018.3577.'}, {'pmid': '21669510', 'type': 'BACKGROUND', 'citation': 'Boet S, Duttchen K, Chan J, Chan AW, Morrish W, Ferland A, Hare GM, Hong AP. Cricoid pressure provides incomplete esophageal occlusion associated with lateral deviation: a magnetic resonance imaging study. J Emerg Med. 2012 May;42(5):606-11. doi: 10.1016/j.jemermed.2011.05.014. Epub 2011 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'Cricoid pressure (CP) confers Grade IIA evidence in preventing gastric insufflation during general anaesthesia. However, a retrospective review of computed tomography scans by Dotson et al. shows that 45% oesophagus is eccentric in the paediatric population aged 1 to 8 years old. In adults, the eccentric oesophagus is associated with reduced CP efficacy in occluding oesophagus. To date, no dynamic real-time study has been done to assess the incidence of the eccentric oesophagus in the paediatric population, the efficacy of CP in occluding eccentric oesophagus, and the effect of anaesthesia on oesophageal position.\n\nAny patients aged 1 to 8 years old are eligible to participate This study will be conducted in the operation theatre of UMMC. The investigators plan to perform an ultrasound of the neck throughout the phases of anaesthetic induction and determine the oesophagus position and its compressibility with CP application.', 'detailedDescription': "In a survey presented by Society for Paediatric Anaesthesia in 2004, 68% of paediatric anaesthesiologists apply CP to prevent passive regurgitation of food into the pharynx. 33% of respondents use CP to prevent gastric insufflation during mask ventilation. Among the respondent, only 24% responded CP reliably occludes the oesophageal lumen.\n\nThe anatomically central oesophagus lies behind cricoid cartilage, by applying CP oesophageal lumen will be occluded. However, it remains debatable if eccentric oesophageal is compressible. Studies were conducted on the adult population. Efficacy of CP has been studied in adult patients by means of magnetic resonance imaging. It was shown that CP was ineffective in occluding the oesophageal lumen in adult patients with an eccentric oesophagus. In addition, the study raised the concern of CP application in itself might result in lateral displacement of the oesophagus. This is further supported by Lim et al.'s study which shows the ineffectiveness of CP in occluding eccentric oesophagus in adult patients.\n\nContrary to the aforementioned studies, Rice et al's demonstrated oesophagus was occludable regardless of the position. The author hypothesized that the hypopharynx and cricoid move as one anatomical unit and the oesophagus would be compressed following the application of CP.\n\nAlthough the effectiveness of CP was extensively studied in the adult population, studies on the paediatric population remained scarce. A retrospective review of computed tomography scans by Dotson et al. shows that 45% oesophagus is eccentric in the paediatric population aged 1 to 8 years old. In our pilot study, the investigators found out that 90 per cent of the oesophagus in the paediatric population was successfully occluded following the application of CP regardless of its position.\n\nCricoid pressure is not without risk. CP was associated with oesophageal rupture. It has been known to disrupt the laryngoscopic view of the glottis and cause difficult intubation. Hence, it would be imperative to investigate whether CP is truly effective in occluding the oesophagus and preventing gastric aspiration in the paediatric population.\n\nThis would be a prospective observational study to study the real-time dynamic effect of oesophageal position and the effect of anaesthesia on oesophageal position. Most importantly, the investigators are hoping to investigate the effectiveness of CP in occluding oesophagus in the paediatric population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ASA 1 and 2 children aged 1 to 8 years old undergoing general anaesthesia for elective surgery requires muscle paralysis and tracheal intubation. We rule out cases which need rapid sequence induction, high risk of aspiration and difficult airway.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA 1, 2\n* Age 1-8 years old\n* Scheduled for surgery under general anaesthesia requiring tracheal intubation\n\nExclusion Criteria:\n\n* Presence of neck mass/ cervical spine pathology, prior neck surgery\n* Pathology of the upper respiratory tract\n* Anticipated difficult intubation / difficult mask ventilation\n* Risk of pulmonary aspiration of gastric contents (eg. Gastroesophageal reflux disease, hiatus hernia, intestinal obstruction)\n* Morbid obesity BMI ≥ 35 kg/m2 (above 85th centile) - overweight patients\n* Inadequate fasting ( 6 hours solid food/ formula milk, 4 hours breast milk and 2 hours clear fluid) - definite indication for rapid sequence induction\n* Uncontrolled cardiopulmonary disease\n* Oesophageal conditions: achalasia, Zenker's diverticulum"}, 'identificationModule': {'nctId': 'NCT05509335', 'briefTitle': 'Ultrasound Assessment On Effectiveness of Cricoid Pressure In Paediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Ultrasound Assessment On Real Time Effectiveness Of Cricoid Pressure In Paediatric Population Under General Anaesthesia', 'orgStudyIdInfo': {'id': '2021329-9999'}}, 'contactsLocationsModule': {'locations': [{'zip': '50603', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Chao Chia Chia, MMed (Anaes)', 'role': 'CONTACT', 'email': 'chaochia@um.edu.my', 'phone': '+(60)163113597'}], 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Chao Chia Cheong, MMed Anaaes', 'role': 'CONTACT', 'email': 'chaochia@um.edu.my', 'phone': '+60163113597'}], 'overallOfficials': [{'name': 'Chew Yin Wang, FRCA', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'result and data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Anaesthesiologist, Lecturer', 'investigatorFullName': 'Dr. Cheong Chao Chia', 'investigatorAffiliation': 'University of Malaya'}}}}