Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Only participant is masked from knowing the assigned group'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old selected.\n* Written informed consent will be obtained prior to enrolment.\n* Randomisation into 2 groups (BUHE and sniffing position) will be done via computer generated sequences. Subsequently, will be placed into sealed envelopes.\n* The next available envelope will be selected and open for that particular patient at the time of enrolment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2019-03-09', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave'}], 'secondaryOutcomes': [{'measure': 'Number of laryngoscopy and intubation attempt', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'Number of attempts taken by investigator to obtain successful endotracheal intubation in both arms'}, {'measure': 'Laryngeal exposure measured via POGO score', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'Percentage of glottic opening during laryngoscopy'}, {'measure': 'Occurrence of difficult intubation', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'Defined as ≥3 attempts at intubation'}, {'measure': 'Occurrence of hypoxia', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'Hypoxia defined as pulse oximetry reading less than 95 percents'}, {'measure': 'The use of any other airway adjunct or external laryngeal manipulation to assist in intubation', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'Change of blade size, bougie, magill forcep, video assisted laryngoscope,external laryngeal manipulation (Use of any airway adjunct is grouped as one)'}, {'measure': 'Occurrence of esophageal intubation', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'Unsuccessful intubation into esophagus'}, {'measure': 'Occurrence of airway trauma', 'timeFrame': 'Intraoperatively , during induction of anaesthesia', 'description': 'broken tooth, bleeding or injury from oral cavity, tongue or lips, etc'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rapid sequence induction', 'Bed up head elevation', 'sniffing position', 'cricoid pressure', 'time taken for intubation in seconds', 'percentage of glottic opening'], 'conditions': ['Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction']}, 'referencesModule': {'references': [{'pmid': '12568178', 'type': 'BACKGROUND', 'citation': 'Brodsky JB. Positioning the morbidly obese patient for anesthesia. Obes Surg. 2002 Dec;12(6):751-8. doi: 10.1381/096089202320995510.'}, {'pmid': '13749923', 'type': 'BACKGROUND', 'citation': 'SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. doi: 10.1016/s0140-6736(61)92485-0. No abstract available.'}, {'pmid': '8068068', 'type': 'BACKGROUND', 'citation': 'Vanner RG, Pryle BJ. Nasogastric tubes and cricoid pressure. Anaesthesia. 1993 Dec;48(12):1112-3. doi: 10.1111/j.1365-2044.1993.tb07560.x. No abstract available.'}, {'pmid': '11983669', 'type': 'BACKGROUND', 'citation': 'Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. doi: 10.1007/BF03017931.'}, {'pmid': '19843793', 'type': 'BACKGROUND', 'citation': 'Rice MJ, Mancuso AA, Gibbs C, Morey TE, Gravenstein N, Deitte LA. Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Anesth Analg. 2009 Nov;109(5):1546-52. doi: 10.1213/ane.0b013e3181b05404.'}, {'pmid': '89335', 'type': 'BACKGROUND', 'citation': "Robinson JS, Thompson JM. Fatal aspiration (Mendelson's) syndrome despite antacids and cricoid pressure. Lancet. 1979 Aug 4;2(8136):228-30. doi: 10.1016/s0140-6736(79)90240-x."}, {'pmid': '2791184', 'type': 'BACKGROUND', 'citation': 'Williamson R. Cricoid pressure. Can J Anaesth. 1989 Sep;36(5):601. doi: 10.1007/BF03005396. No abstract available.'}, {'pmid': '10209365', 'type': 'BACKGROUND', 'citation': 'Kluger MT, Short TG. Aspiration during anaesthesia: a review of 133 cases from the Australian Anaesthetic Incident Monitoring Study (AIMS). Anaesthesia. 1999 Jan;54(1):19-26. doi: 10.1046/j.1365-2044.1999.00642.x.'}, {'pmid': '7856895', 'type': 'BACKGROUND', 'citation': 'Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007.'}, {'pmid': '9337361', 'type': 'BACKGROUND', 'citation': 'Thibodeau LG, Verdile VP, Bartfield JM. Incidence of aspiration after urgent intubation. Am J Emerg Med. 1997 Oct;15(6):562-5. doi: 10.1016/s0735-6757(97)90157-1.'}, {'pmid': '493710', 'type': 'BACKGROUND', 'citation': 'Tomkinson J, Turnbull A, Robson G, Cloake E, Adelstein AM, Weatherall J. Report on confidential enquiries into maternal deaths in England and Wales 1973-1975. Rep Health Soc Subj (Lond). 1979;14:1-166. No abstract available.'}, {'pmid': '22656679', 'type': 'BACKGROUND', 'citation': "Guirro UB, Martins CR, Munechika M. Assessment of anesthesiologists' rapid sequence induction technique in an university hospital. Rev Bras Anestesiol. 2012 May-Jun;62(3):335-45. doi: 10.1016/S0034-7094(12)70134-4."}, {'pmid': '11736671', 'type': 'BACKGROUND', 'citation': 'Schmidt A, Akeson J. Practice and knowledge of cricoid pressure in southern Sweden. Acta Anaesthesiol Scand. 2001 Nov;45(10):1210-4. doi: 10.1034/j.1399-6576.2001.451006.x.'}, {'pmid': '8280541', 'type': 'BACKGROUND', 'citation': 'Brimacombe J, White A, Berry A. Effect of cricoid pressure on ease of insertion of the laryngeal mask airway. Br J Anaesth. 1993 Dec;71(6):800-2. doi: 10.1093/bja/71.6.800.'}, {'pmid': '9349075', 'type': 'BACKGROUND', 'citation': 'Vanner RG, Clarke P, Moore WJ, Raftery S. The effect of cricoid pressure and neck support on the view at laryngoscopy. Anaesthesia. 1997 Sep;52(9):896-900. doi: 10.1111/j.1365-2044.1997.181-az0315.x.'}, {'pmid': '15681945', 'type': 'BACKGROUND', 'citation': 'Turgeon AF, Nicole PC, Trepanier CA, Marcoux S, Lessard MR. Cricoid pressure does not increase the rate of failed intubation by direct laryngoscopy in adults. Anesthesiology. 2005 Feb;102(2):315-9. doi: 10.1097/00000542-200502000-00012.'}, {'pmid': '11207469', 'type': 'BACKGROUND', 'citation': 'Adnet F, Racine SX, Borron SW, Clemessy JL, Fournier JL, Lapostolle F, Cupa M. A survey of tracheal intubation difficulty in the operating room: a prospective observational study. Acta Anaesthesiol Scand. 2001 Mar;45(3):327-32. doi: 10.1034/j.1399-6576.2001.045003327.x.'}, {'pmid': '20775829', 'type': 'BACKGROUND', 'citation': 'Magill IW. TECHNIQUE IN ENDOTRACHEAL ANAESTHESIA. Br Med J. 1930 Nov 15;2(3645):817-9. doi: 10.1136/bmj.2.3645.817. No abstract available.'}, {'pmid': '2917111', 'type': 'BACKGROUND', 'citation': 'Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.'}, {'pmid': '11605919', 'type': 'BACKGROUND', 'citation': 'Isono S. Common practice and concepts in anesthesia: time for reassessment: is the sniffing position a "gold standard" for laryngoscopy? Anesthesiology. 2001 Oct;95(4):825-7. doi: 10.1097/00000542-200110000-00007. No abstract available.'}, {'pmid': '28928584', 'type': 'BACKGROUND', 'citation': 'Akhtar M, Ali Z, Hassan N, Mehdi S, Wani GM, Mir AH. A Randomized Study Comparing the Sniffing Position with Simple Head Extension for Glottis Visualization and Difficulty in Intubation during Direct Laryngoscopy. Anesth Essays Res. 2017 Jul-Sep;11(3):762-766. doi: 10.4103/0259-1162.204206.'}, {'pmid': '11867407', 'type': 'BACKGROUND', 'citation': 'Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.'}, {'pmid': '15527629', 'type': 'BACKGROUND', 'citation': 'Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.'}, {'pmid': '22301204', 'type': 'BACKGROUND', 'citation': 'Lebowitz PW, Shay H, Straker T, Rubin D, Bodner S. Shoulder and head elevation improves laryngoscopic view for tracheal intubation in nonobese as well as obese individuals. J Clin Anesth. 2012 Mar;24(2):104-8. doi: 10.1016/j.jclinane.2011.06.015. Epub 2012 Feb 1.'}, {'pmid': '17611252', 'type': 'BACKGROUND', 'citation': 'Lee BJ, Kang JM, Kim DO. Laryngeal exposure during laryngoscopy is better in the 25 degrees back-up position than in the supine position. Br J Anaesth. 2007 Oct;99(4):581-6. doi: 10.1093/bja/aem095. Epub 2007 Jul 4.'}, {'pmid': '27300036', 'type': 'BACKGROUND', 'citation': 'Turner JS, Ellender TJ, Okonkwo ER, Stepsis TM, Stevens AC, Eddy CS, Sembroski EG, Perkins AJ, Cooper DD. Cross-over study of novice intubators performing endotracheal intubation in an upright versus supine position. Intern Emerg Med. 2017 Jun;12(4):513-518. doi: 10.1007/s11739-016-1481-z. Epub 2016 Jun 14.'}, {'pmid': '28487139', 'type': 'BACKGROUND', 'citation': 'Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.'}, {'pmid': '27852241', 'type': 'BACKGROUND', 'citation': 'Reddy RM, Adke M, Patil P, Kosheleva I, Ridley S; Anaesthetic Department at Glan Clwyd Hospital. Comparison of glottic views and intubation times in the supine and 25 degree back-up positions. BMC Anesthesiol. 2016 Nov 16;16(1):113. doi: 10.1186/s12871-016-0280-4.'}, {'pmid': '25468586', 'type': 'BACKGROUND', 'citation': 'El-Orbany MI, Getachew YB, Joseph NJ, Salem MR, Friedman M. Head elevation improves laryngeal exposure with direct laryngoscopy. J Clin Anesth. 2015 Mar;27(2):153-8. doi: 10.1016/j.jclinane.2014.09.012. Epub 2014 Nov 22.'}, {'pmid': '12605198', 'type': 'BACKGROUND', 'citation': 'Levitan RM, Mechem CC, Ochroch EA, Shofer FS, Hollander JE. Head-elevated laryngoscopy position: improving laryngeal exposure during laryngoscopy by increasing head elevation. Ann Emerg Med. 2003 Mar;41(3):322-30. doi: 10.1067/mem.2003.87.'}, {'pmid': '19020138', 'type': 'BACKGROUND', 'citation': 'Rao SL, Kunselman AR, Schuler HG, DesHarnais S. Laryngoscopy and tracheal intubation in the head-elevated position in obese patients: a randomized, controlled, equivalence trial. Anesth Analg. 2008 Dec;107(6):1912-8. doi: 10.1213/ane.0b013e31818556ed.'}, {'pmid': '28202295', 'type': 'BACKGROUND', 'citation': 'Turner JS, Ellender TJ, Okonkwo ER, Stepsis TM, Stevens AC, Sembroski EG, Eddy CS, Perkins AJ, Cooper DD. Feasibility of upright patient positioning and intubation success rates At two academic EDs. Am J Emerg Med. 2017 Jul;35(7):986-992. doi: 10.1016/j.ajem.2017.02.011. Epub 2017 Feb 5.'}, {'pmid': '8457057', 'type': 'BACKGROUND', 'citation': 'Hastings RH, Kelley SD. Neurologic deterioration associated with airway management in a cervical spine-injured patient. Anesthesiology. 1993 Mar;78(3):580-3. doi: 10.1097/00000542-199303000-00022. No abstract available.'}, {'pmid': '26866753', 'type': 'BACKGROUND', 'citation': 'Khandelwal N, Khorsand S, Mitchell SH, Joffe AM. Head-Elevated Patient Positioning Decreases Complications of Emergent Tracheal Intubation in the Ward and Intensive Care Unit. Anesth Analg. 2016 Apr;122(4):1101-7. doi: 10.1213/ANE.0000000000001184.'}, {'pmid': '15915022', 'type': 'BACKGROUND', 'citation': "Dixon BJ, Dixon JB, Carden JR, Burn AJ, Schachter LM, Playfair JM, Laurie CP, O'Brien PE. Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study. Anesthesiology. 2005 Jun;102(6):1110-5; discussion 5A. doi: 10.1097/00000542-200506000-00009."}, {'pmid': '12630606', 'type': 'BACKGROUND', 'citation': 'Boyce JR, Ness T, Castroman P, Gleysteen JJ. A preliminary study of the optimal anesthesia positioning for the morbidly obese patient. Obes Surg. 2003 Feb;13(1):4-9. doi: 10.1381/096089203321136511.'}, {'pmid': '15567809', 'type': 'BACKGROUND', 'citation': 'Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed to conduct a randomised controlled trial comparing endotracheal intubation (ETI) in bed up head elevation BUHE position versus sniffing position in simulated rapid sequence induction (RSI).\n\nObjective is to determine if the time taken for intubation in the bed up head elevated position is non-inferior to time taken for intubation in the sniffing position.\n\nThe hypotheses:\n\n1. In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position is non inferior to time required for DL and successful ETI in the sniffing position.\n2. In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position improve POGO score.\n3. In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position reduces airway related complications.\n\nTerminology:\n\nDirect laryngoscopy (DL) and Endotracheal intubation (ETI): Is a method of inserting a breathing tube into the trachea (windpipe) once patient undergo general anaesthesia.\n\nBed up head elevation (BUHE): Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.\n\nSniffing position: Maintaining supine position with head elevation with head rest.\n\nRapid sequence induction (RSI): An established method of inducing anaesthesia in patients who are at risk of aspiration of gastric contents into the lungs. It involves loss of consciousness during cricoid pressure followed by intubation without face mask ventilation. The aim is to intubate the trachea as quickly and as safely as possible.\n\nPOGO score: Percentage of glottic opening\n\nCricoid Pressure (CP): Maneuvre to prevent regurgitation of gastric contents during induction of anaesthesia by temporary occlusion of the upper end of the esophagus by backward pressure of cricoid cartilage against bodies of cervical vertebrae.', 'detailedDescription': 'All patients from age 18 years old to 75 years old undergoing elective surgery under general anaesthesia in operating theater of University Malaya Medical Centre over a period of 15 months, from April 2018 to June 2019 will be included and recruited based on inclusion and exclusion criteria.\n\nThose patient that fulfilled the criteria and consented for the study will be randomized to 2 group.\n\ni) BUHE group: Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.\n\nii) Sniffing group: Maintaining supine position with head elevation with head rest (foam donut).\n\nInduction of anaesthesia starts with:\n\n* preoxygenation with 100% oxygen for 3-5 min performed until end tidal oxygen of 85% achieved.\n* A pre-calculated dose of induction agent is administered, followed immediately by a neuromuscular blocking agent.\n\n(IV Fentanyl 2mcg/kg,IV Propofol 2-3mg/kg,IV Rocuronium 1mg/kg).\n\n* Cricoid pressure at 10 Newton is applied increasing to 30 Newton once consciousness is lost.\n* After adequate neuromuscular blockade,both group patients will be intubated by one investigator via direct laryngoscopy using Macintosh blade size 3 or 4.\n* Time taken from insertion of Macintosh blade into oral cavity till confirmation of endotracheal tube placement via detection of CO2 on the end tidal CO2 monitor will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old.\n\nExclusion Criteria:\n\n* Patients with airway obstruction\n* Patients with contraindication to neck extension\n* BMI\\> 35kg/m2\n* Patient with history of difficult airway from previous intubation history\n* Only single intubation will be included if patients had multiple surgery during their hospital stay\n* Patients with ischaemic heart disease, cerebrovascular diseases and respiratory disease'}, 'identificationModule': {'nctId': 'NCT03912935', 'briefTitle': 'Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'MREC ID NO: 2018222-6042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Sniffing position', 'description': 'Subject will be maintained in standard intubation position which is supine position with head elevation with head rest (foam donut).'}, {'type': 'EXPERIMENTAL', 'label': 'Bed up head elevation position', 'description': 'Subject will be maintained at bed up 20-30 degree aiming alignment between the external auditory meatus with sternal notch', 'interventionNames': ['Other: comparison between two different intubating position']}], 'interventions': [{'name': 'comparison between two different intubating position', 'type': 'OTHER', 'description': 'Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases', 'armGroupLabels': ['Bed up head elevation position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Shahmini Ganesh, MD', 'role': 'CONTACT', 'email': 'shahminig2805@gmail.com', 'phone': '0379492052'}, {'name': 'Samuel Tsan Ern Hung, MD', 'role': 'CONTACT', 'email': 'samuel.tsan@gmail.com', 'phone': '0379492052'}], 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Shahmini Ganesh, MD', 'role': 'CONTACT', 'email': 'shahminig2805@gmail.com', 'phone': '0379492052'}, {'name': 'Samuel Tsan Ern Hung, MD', 'role': 'CONTACT', 'email': 'samuel.tsan@gmail.com', 'phone': '0379492052'}], 'overallOfficials': [{'name': 'Shahmini Ganesh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data that already summarized and analysed in the form of schematic diagram will be available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Shahmini a/p Ganesh', 'investigatorAffiliation': 'University of Malaya'}}}}