Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02708420
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2016-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Glidescope Video Laryngoscope is Related to Less Hemodynamic Response?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-12', 'studyFirstSubmitDate': '2016-02-27', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in systolic blood pressure', 'timeFrame': '5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes', 'description': 'invasive blood pressure (mmHg) monitoring'}, {'measure': 'Change in heart rate', 'timeFrame': '5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes', 'description': 'Heart rate (beats per minute) will be measured before induction, and throughout and after laryngoscopy'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': '5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes', 'description': 'invasive blood pressure (mmHg) monitoring'}, {'measure': 'Change in mean arterial pressure', 'timeFrame': '5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes', 'description': 'invasive blood pressure (mmHg) monitoring'}], 'secondaryOutcomes': [{'measure': 'Procedure time', 'timeFrame': '10 minutes', 'description': 'Total laryngoscopy and intubation time (minutes)'}, {'measure': 'Cormack lehane laryngoscopic view will be recorded', 'timeFrame': '10 minutes', 'description': 'laryngoscopic view data will be recorded according to Cormack Lehane scale (A Scale with 1-4)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glidescope', 'Cardiovascular surgery', 'Macintosh Laryngoscope', 'Hemodynamic response', 'Anesthesia'], 'conditions': ['Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '26760401', 'type': 'BACKGROUND', 'citation': 'Friedman Z, Gurevich L, Siddiqui N. The effect of a modified GlideScope intubation technique on procedure times, airway morbidity and haemodynamic response. Eur J Anaesthesiol. 2016 Mar;33(3):229-30. doi: 10.1097/EJA.0000000000000339. No abstract available.'}, {'pmid': '25866708', 'type': 'BACKGROUND', 'citation': 'Amini S, Shakib M. Hemodynamic changes following endotracheal intubation in patients undergoing cesarean section with general anesthesia: application of glidescope(R) videolaryngoscope versus direct laryngoscope. Anesth Pain Med. 2015 Mar 30;5(2):e21836. doi: 10.5812/aapm.21836. eCollection 2015 Apr.'}, {'pmid': '25478537', 'type': 'BACKGROUND', 'citation': 'Dashti M, Amini S, Azarfarin R, Totonchi Z, Hatami M. Hemodynamic changes following endotracheal intubation with glidescope((R)) video-laryngoscope in patients with untreated hypertension. Res Cardiovasc Med. 2014 May;3(2):e17598. doi: 10.5812/cardiovascmed.17598. Epub 2014 Apr 1.'}, {'pmid': '25225515', 'type': 'BACKGROUND', 'citation': 'Aqil M. A study of stress response to endotracheal intubation comparing glidescope and flexible fiberoptic bronchoscope. Pak J Med Sci. 2014 Sep;30(5):1001-6. doi: 10.12669/pjms.305.4788.'}, {'pmid': '24910788', 'type': 'BACKGROUND', 'citation': 'Pournajafian AR, Ghodraty MR, Faiz SH, Rahimzadeh P, Goodarzynejad H, Dogmehchi E. Comparing GlideScope Video Laryngoscope and Macintosh Laryngoscope Regarding Hemodynamic Responses During Orotracheal Intubation: A Randomized Controlled Trial. Iran Red Crescent Med J. 2014 Apr;16(4):e12334. doi: 10.5812/ircmj.12334. Epub 2014 Apr 5.'}, {'pmid': '23610856', 'type': 'BACKGROUND', 'citation': 'Maassen RL, Pieters BM, Maathuis B, Serroyen J, Marcus MA, Wouters P, van Zundert AA. Endotracheal intubation using videolaryngoscopy causes less cardiovascular response compared to classic direct laryngoscopy, in cardiac patients according a standard hospital protocol. Acta Anaesthesiol Belg. 2012;63(4):181-6.'}, {'pmid': '19417675', 'type': 'BACKGROUND', 'citation': 'Siddiqui N, Katznelson R, Friedman Z. Heart rate/blood pressure response and airway morbidity following tracheal intubation with direct laryngoscopy, GlideScope and Trachlight: a randomized control trial. Eur J Anaesthesiol. 2009 Sep;26(9):740-5. doi: 10.1097/EJA.0b013e32832b138d.'}, {'pmid': '17572317', 'type': 'BACKGROUND', 'citation': 'Xue FS, Zhang GH, Li XY, Sun HT, Li P, Li CW, Liu KP. Comparison of hemodynamic responses to orotracheal intubation with the GlideScope videolaryngoscope and the Macintosh direct laryngoscope. J Clin Anesth. 2007 Jun;19(4):245-50. doi: 10.1016/j.jclinane.2006.11.004.'}, {'pmid': '22352799', 'type': 'BACKGROUND', 'citation': 'Russell T, Khan S, Elman J, Katznelson R, Cooper RM. Measurement of forces applied during Macintosh direct laryngoscopy compared with GlideScope(R) videolaryngoscopy. Anaesthesia. 2012 Jun;67(6):626-31. doi: 10.1111/j.1365-2044.2012.07087.x. Epub 2012 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients.', 'detailedDescription': 'Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients. After induction with our institutional protocol for cardiac bypass surgery, hemodynamic data including heart rate, systolic and diastolic arterial pressure data will be recorded. Time for intubation, age, sex, ASA status data will also be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical Status 2-3\n* Patients undergoing elective cardiac bypass surgery\n\nExclusion Criteria:\n\n* Difficult intubation history\n* Need for Rapid sequence intubation or alternative intubation method\n* Emergency procedures\n* Patients that have predictive factors for difficult intubation\n* Patients with permanent pacemaker'}, 'identificationModule': {'nctId': 'NCT02708420', 'briefTitle': 'Does Glidescope Video Laryngoscope is Related to Less Hemodynamic Response?', 'organization': {'class': 'OTHER', 'fullName': 'Gata Haydarpasa Research Hospital'}, 'officialTitle': 'Comparison of Hemodynamic Responses to Endotracheal Intubation With Glidescope Video Laryngoscope and Macintosh Direct Laryngoscope in Patients Undergoing Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'GataHRH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Glidescope intubation', 'description': 'This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.', 'interventionNames': ['Device: Glidescope']}, {'type': 'OTHER', 'label': 'Macintosh Laryngoscope', 'description': 'This standard technique involves laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.', 'interventionNames': ['Device: Macintosh Laryngoscope']}], 'interventions': [{'name': 'Glidescope', 'type': 'DEVICE', 'description': 'This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.', 'armGroupLabels': ['Glidescope intubation']}, {'name': 'Macintosh Laryngoscope', 'type': 'DEVICE', 'description': 'This technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.', 'armGroupLabels': ['Macintosh Laryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'state': 'Asia', 'country': 'Turkey (Türkiye)', 'facility': 'GATA Haydarpasa Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Sezai Ozkan, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Gata Haydarpasa Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gata Haydarpasa Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}