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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 December 2015 |
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Main ID: |
NCT02564640 |
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Date of registration:
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28/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Hemodynamic Changes by Using the Videolaryngoscope and the Macintosh Laryngoscope
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Scientific title:
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Comparison of Hemodynamic Changes After Endotracheal Intubation by Using the Videolaryngoscope and the Macintosh Direct Laryngoscope in Elderly Hypertensive Patients |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02564640 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Nilgun Kavrut Ozturk, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Antalya Training and Research Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- American Society of Anesthesiologists Physical Status II-III,
- aged over 65 years,
- controlled hypertensive patients,
- scheduled for elective coronary artery bypass grafting.
Exclusion Criteria:
- American Society of Anesthesiologists Physical Status IV,
- ejection fraction < 40%,
- any anatomical abnormality in head, neck or face,
- Mallampati score of IV,
- history of difficult intubation or laryngoscopy
Age minimum:
65 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anesthesia Intubation Complication
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Intervention(s)
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Device: Macintosh laryngoscope
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Device: videolaryngoscope
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Primary Outcome(s)
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Blood pressure changes during tracheal intubation ( mmHg ) ,
[Time Frame: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation]
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Secondary Outcome(s)
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Arrhythmic changes in electrocardiogram during tracheal intubation
[Time Frame: At baseline, 1 and 5 minutes after tracheal intubation.]
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Heart rate changes during tracheal intubation (beats per minute)
[Time Frame: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation]
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ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation
[Time Frame: At baseline, 1 and 5 minutes after tracheal intubation.]
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Secondary ID(s)
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AntalyaTRH 008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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