Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT02201628
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2014-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emilysaffer@gmail.com', 'phone': '07890549924', 'title': 'Dr Emily Haberman', 'organization': "King's College Hospital NHS Foundation Trust"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cuff Inflation and Cuff Deflation Groups', 'description': 'Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak', 'otherNumAtRisk': 59, 'otherNumAffected': 3, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nosebleed', 'notes': 'On insertion of nasopharyngeal temperature probe. Minor and self-resolved', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-extubation stridor', 'notes': 'Self-resolved without medical therapy. Associated with use of Microcuff endotracheal tube', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Partially obstructed ETT during emergence', 'notes': 'Associated with use of Microcuff endotracheal tube. Required suctioning with suction catheter, thereafter no further complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cuff Inflation and Cuff Deflation Groups', 'description': 'Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx.\n\nThis will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.', 'unitOfMeasure': 'temperature difference degrees celsius', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%)', 'timeFrame': '6 months', 'description': 'Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cuff Inflation and Cuff Deflation Groups', 'description': 'Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '9 were excluded due to incomplete data or insufficient FVL difference between cuff down and cuff up scenarios'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cuff Inflation and Cuff Deflation Groups', 'description': 'Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG000', 'lowerLimit': '1.8', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-03-18', 'size': 459737, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-09T19:35', 'hasProtocol': True}, {'date': '2014-06-24', 'size': 212395, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-09T19:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2014-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2014-07-15', 'resultsFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-29', 'studyFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx', 'timeFrame': '6 months', 'description': 'Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx.\n\nThis will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.'}], 'secondaryOutcomes': [{'measure': 'Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%)', 'timeFrame': '6 months', 'description': 'Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oesophageal', 'Nasopharyngeal', 'temperature', 'Intubation, endotracheal', 'Pediatric', 'Anesthesia', 'Hypothermia'], 'conditions': ['Child']}, 'referencesModule': {'references': [{'pmid': '19137809', 'type': 'BACKGROUND', 'citation': 'Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.'}, {'pmid': '11506130', 'type': 'BACKGROUND', 'citation': 'Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.'}, {'pmid': '20218415', 'type': 'BACKGROUND', 'citation': 'Evans DC, Doraiswamy VA, Prosciak MP, Silviera M, Seamon MJ, Rodriguez Funes V, Cipolla J, Wang CF, Kavuturu S, Torigian DA, Cook CH, Lindsey DE, Steinberg SM, Stawicki SP. Complications associated with pulmonary artery catheters: a comprehensive clinical review. Scand J Surg. 2009;98(4):199-208. doi: 10.1177/145749690909800402.'}, {'pmid': '9787697', 'type': 'BACKGROUND', 'citation': 'Robinson JL, Seal RF, Spady DW, Joffres MR. Comparison of esophageal, rectal, axillary, bladder, tympanic, and pulmonary artery temperatures in children. J Pediatr. 1998 Oct;133(4):553-6. doi: 10.1016/s0022-3476(98)70067-8.'}, {'pmid': '13376459', 'type': 'BACKGROUND', 'citation': 'SEVERINGHAUS JW, STUPFEL M. Internal body temperature gradients during anesthesia and hypothermia and effect of vagotomy. J Appl Physiol. 1956 Nov;9(3):380-6. doi: 10.1152/jappl.1956.9.3.380. No abstract available.'}, {'pmid': '5710916', 'type': 'BACKGROUND', 'citation': 'Whitby JD, Dunkin LJ. Temperature differences in the oesophagus. Preliminary study. Br J Anaesth. 1968 Dec;40(12):991-5. doi: 10.1093/bja/40.12.991. No abstract available.'}, {'pmid': '5488350', 'type': 'BACKGROUND', 'citation': 'Whitby JD, Dunkin LJ. Oesophageal temperature differences in children. Br J Anaesth. 1970 Nov;42(11):1013-5. doi: 10.1093/bja/42.11.1013. No abstract available.'}, {'pmid': '15302054', 'type': 'BACKGROUND', 'citation': 'Kaukuntla H, Harrington D, Bilkoo I, Clutton-Brock T, Jones T, Bonser RS. Temperature monitoring during cardiopulmonary bypass--do we undercool or overheat the brain? Eur J Cardiothorac Surg. 2004 Sep;26(3):580-5. doi: 10.1016/j.ejcts.2004.05.004.'}, {'pmid': '8452743', 'type': 'BACKGROUND', 'citation': 'Holtzclaw BJ. Monitoring body temperature. AACN Clin Issues Crit Care Nurs. 1993 Feb;4(1):44-55.'}, {'pmid': '7856892', 'type': 'BACKGROUND', 'citation': 'Stone JG, Young WL, Smith CR, Solomon RA, Wald A, Ostapkovich N, Shrebnick DB. Do standard monitoring sites reflect true brain temperature when profound hypothermia is rapidly induced and reversed? Anesthesiology. 1995 Feb;82(2):344-51. doi: 10.1097/00000542-199502000-00004.'}, {'pmid': '14706007', 'type': 'BACKGROUND', 'citation': 'Maxton FJ, Justin L, Gillies D. Estimating core temperature in infants and children after cardiac surgery: a comparison of six methods. J Adv Nurs. 2004 Jan;45(2):214-22. doi: 10.1046/j.1365-2648.2003.02883.x.'}, {'pmid': '5564234', 'type': 'BACKGROUND', 'citation': 'Whitby JD, Dunkin LJ. Cerebral, oesophageal and nasopharyngeal temperatures. Br J Anaesth. 1971 Jul;43(7):673-6. doi: 10.1093/bja/43.7.673. No abstract available.'}, {'pmid': '23314108', 'type': 'BACKGROUND', 'citation': 'Litman RS, Maxwell LG. Cuffed versus uncuffed endotracheal tubes in pediatric anesthesia: the debate should finally end. Anesthesiology. 2013 Mar;118(3):500-1. doi: 10.1097/ALN.0b013e318282cc8f. No abstract available.'}, {'pmid': '758430', 'type': 'BACKGROUND', 'citation': 'Strobel CT, Byrne WJ, Ament ME, Euler AR. Correlation of esophageal lengths in children with height: application to the Tuttle test without prior esophageal manometry. J Pediatr. 1979 Jan;94(1):81-4. doi: 10.1016/s0022-3476(79)80361-3. No abstract available.'}, {'pmid': '18648241', 'type': 'BACKGROUND', 'citation': 'Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.'}, {'pmid': '3878219', 'type': 'BACKGROUND', 'citation': 'Ramsay JG, Ralley FE, Whalley DG, DelliColli P, Wynands JE. Site of temperature monitoring and prediction of afterdrop after open heart surgery. Can Anaesth Soc J. 1985 Nov;32(6):607-12. doi: 10.1007/BF03011406.'}, {'pmid': '11235453', 'type': 'BACKGROUND', 'citation': 'Cronin K, Wallis M. Temperature taking in the ICU: which route is best? Aust Crit Care. 2000 May;13(2):59-64. doi: 10.1016/s1036-7314(00)70623-0.'}, {'pmid': '11398702', 'type': 'BACKGROUND', 'citation': 'Ko HK, Flemmer A, Haberl C, Simbruner G. Methodological investigation of measuring nasopharyngeal temperature as noninvasive brain temperature analogue in the neonate. Intensive Care Med. 2001 Apr;27(4):736-42. doi: 10.1007/s001340000829.'}, {'pmid': '6829963', 'type': 'BACKGROUND', 'citation': 'Muravchick S. Deep body thermometry during general anesthesia. Anesthesiology. 1983 Mar;58(3):271-5. doi: 10.1097/00000542-198303000-00014. No abstract available.'}, {'pmid': '19392849', 'type': 'BACKGROUND', 'citation': 'Wass CT, Long TR, Deschamps C. Entrapment of a nasopharyngeal temperature probe: an unusual complication during an apparently uneventful elective revision laparoscopic Nissen fundoplication. Dis Esophagus. 2010 Jan;23(1):33-5. doi: 10.1111/j.1442-2050.2009.00968.x. Epub 2009 Apr 15.'}, {'pmid': '12437729', 'type': 'BACKGROUND', 'citation': 'Williams DJ, Kelleher AA. Defective nasopharyngeal temperature probes. Anaesthesia. 2002 Dec;57(12):1223; author reply 1223-4. doi: 10.1046/j.1365-2044.2002.02913_18.x. No abstract available.'}, {'pmid': '23161807', 'type': 'BACKGROUND', 'citation': 'Paik UH, Lee TR, Kang MJ, Shin TG, Sim MS, Jo IJ, Song KJ, Jeong YK. Success rates and procedure times of oesophageal temperature probe insertion for therapeutic hypothermia treatment of cardiac arrest according to insertion methods in the emergency department. Emerg Med J. 2013 Nov;30(11):896-900. doi: 10.1136/emermed-2012-201579. Epub 2012 Nov 17.'}, {'pmid': '23061742', 'type': 'BACKGROUND', 'citation': 'Smith JH, Keltie K, Murphy T, Raj N, Lane M, Ranger M, Sims AJ. A comparison of three methods that assess tracheal tube leakage: leak conductance, fractional volume loss, and audible assessment. Paediatr Anaesth. 2013 Feb;23(2):111-6. doi: 10.1111/pan.12043. Epub 2012 Oct 13.'}, {'pmid': '5798841', 'type': 'RESULT', 'citation': 'Whitby JD, Dunkin LJ. Temperature differences in the oesophagus. The effects of intubation and ventilation. Br J Anaesth. 1969 Jul;41(7):615-8. doi: 10.1093/bja/41.7.615. No abstract available.'}, {'pmid': '8478651', 'type': 'RESULT', 'citation': 'Bloch EC, Ginsberg B, Binner RA Jr. The esophageal temperature gradient in anesthetized children. J Clin Monit. 1993 Apr;9(2):73-7. doi: 10.1007/BF01616917.'}, {'pmid': '2394660', 'type': 'RESULT', 'citation': 'Mekjavic IB, Rempel ME. Determination of esophageal probe insertion length based on standing and sitting height. J Appl Physiol (1985). 1990 Jul;69(1):376-9. doi: 10.1152/jappl.1990.69.1.376.'}, {'pmid': '21603336', 'type': 'RESULT', 'citation': 'Taylor C, Subaiya L, Corsino D. Pediatric cuffed endotracheal tubes: an evolution of care. Ochsner J. 2011 Spring;11(1):52-6.'}, {'pmid': '9813517', 'type': 'RESULT', 'citation': 'Matsukawa T, Ozaki M, Sessler DI, Nishiyama T, Imamura M, Kumazawa T. Accuracy and precision of "deep sternal" and tracheal temperatures at high- and low-fresh-gas flows. Br J Anaesth. 1998 Aug;81(2):171-5. doi: 10.1093/bja/81.2.171.'}, {'pmid': '19887533', 'type': 'RESULT', 'citation': 'Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.'}], 'seeAlsoLinks': [{'url': 'https://www.nice.org.uk/guidance/cg65/update/CG65/documents/perioperative-hypothermia-inadvertent-guideline-full-guideline-part-12', 'label': 'National Institute for Health and Clinical Excellence. The management of inadvertent perioperative hypothermia in adults: full guideline'}]}, 'descriptionModule': {'briefSummary': 'Children lose heat under general anaesthesia, thus temperature is routinely monitored during anaesthesia for all but the shortest cases, and active warming can be used to prevent hypothermia and its resulting complications. Temperature can be measured at several sites dependent on the type of surgery and patient factors. Previously a temperature probe has been sited in the lower third of the oesophagus (swallowing tube) but it is difficult to accurately place this without an X-Ray. Consequently it is more common to use a temperature probe placed in the nasopharynx (where the nose and throat meet), when the child is anaesthetised.\n\nHowever the investigators do not know if the temperature in the nasopharynx correlates well with the real core temperature or not.This prospective, unblinded, agreement study will seek to find an agreement of 2 methods to measure temperature in children undergoing general anaesthesia with a breathing tube that has a leak.', 'detailedDescription': 'It is known that temperature in the lower third of the oesophagus correlates well with the gold standard of core temperature measurement, namely the temperature of blood in the heart. It is not known if oesophageal and nasopharyngeal temperatures correlate in children on a breathing machine via a tube with leak. If this study were to find a good correlation between oesophageal and nasopharyngeal temperature, this would allow clinicians to confidently use the more feasible nasopharyngeal temperature probes.\n\nFor this study 100 children will have both nasopharyngeal and oesophageal temperatures measured during general anaesthesia, both in the presence and absence of a leak around the endotracheal tube.\n\nIt is hypothesised that even in the presence of a leak, the temperature difference between the two methods will be less than 0.5 degrees centigrade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '8 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requires general anaesthesia with endotracheal intubation for a procedure assisted by radiography (e.g. line insertion, line change).\n* Patient requires chest radiograph for procedure.\n* Expected anaesthetic time more than 30 minutes.\n\nExclusion Criteria:\n\n* No written parental written consent.\n* Known oesophageal pathology (e.g. tracheo-oesophageal fistula, oesophageal strictures, oesophageal varices, oesophageal atresia).\n* Known base of skull or midface fractures.\n* Previous gastric bypass surgery or nasal surgery.\n* Known coagulopathy.\n* Previous alkaline ingestion.\n* High aspiration risk.\n* Significant respiratory co-morbidity requiring anticipated peak airway pressures \\> 25 cm of water\n* American Society Anaesthesiologists (ASA) grading 4 - 5.\n* Tracheostomy in situ.\n* Severe sepsis or septic shock or other other condition (such as bronchopulmonary fistula) that precludes use of tidal volume ventilation over 7 ml/kg.\n* Known airway abnormalities (e.g. subglottic stenosis) that preclude placement of a MicroCuff® endotracheal tube.\n* Oesophageal or nasopharyngeal probe contraindicated for reasons related to surgery / procedure.'}, 'identificationModule': {'nctId': 'NCT02201628', 'briefTitle': 'Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children', 'organization': {'class': 'OTHER', 'fullName': 'Great Ormond Street Hospital for Children NHS Foundation Trust'}, 'officialTitle': 'Comparison of Nasopharyngeal and Lower Oesophageal Temperatures Under General Anaesthesia With an Endotracheal Tube With Leak', 'orgStudyIdInfo': {'id': '14SG04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasopharyngeal and oesophageal temperatures', 'description': 'An oesophageal and nasopharyngeal temperature probe will be placed and temperature will be measured at these site', 'interventionNames': ['Device: Nasopharyngeal and oesophageal temperature probes']}], 'interventions': [{'name': 'Nasopharyngeal and oesophageal temperature probes', 'type': 'DEVICE', 'otherNames': ['Covidien', 'Mon-a-therm™ General Purpose Temperature Probe 400TM', '90050'], 'armGroupLabels': ['Nasopharyngeal and oesophageal temperatures']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Aarjan P Snoek, MBChB, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust'}, {'name': 'Helen V Hume-Smith, MBBS, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust'}, {'name': 'Emily Haberman, MBBS, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Great Ormond Street Hospital for Children NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}