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Comparison of Hemodynamic Changes by Using the Videolaryngoscope and the Macintosh Laryngoscope

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ClinicalTrials.gov Identifier: NCT02564640
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

Brief Summary:
Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs comparatively less airway manipulation so, the investigators expect less hemodynamic response while using videolaryngoscope.

Condition or disease Intervention/treatment Phase
Anesthesia Intubation Complication Device: videolaryngoscope Device: Macintosh laryngoscope Not Applicable

Detailed Description:

The hemodynamic stress response to tracheal intubation can precipitate adverse cardiovascular events in patients with cardiovascular disease. Which is shown to greatly increase the risk of myocardial infarction or stroke, especially in elderly patients with hypertension. Direct laryngoscopy and laryngoscopic stimulation of pharyngolaryngeal structures may be an important factor in the hemodynamic stress response associated with tracheal intubation.

Patients were randomly allocated to two groups using a permuted block randomization method: 1) patients intubated by using the videolaryngoscopy 2) patients intubated by using the Macintosh laryngoscope . SAP, MAP, and heart rate were measured and recorded in the operating room: At baseline, before intubation, immediately after intubation and 1,2,3,4 and 5 minutes after tracheal intubation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Hemodynamic Changes After Endotracheal Intubation by Using the Videolaryngoscope and the Macintosh Direct Laryngoscope in Elderly Hypertensive Patients
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Active Comparator: videolaryngoscope
patients intubated by using the videolaryngoscopy
Device: videolaryngoscope
patients intubated by using the videolaryngoscope

Active Comparator: Macintosh laryngoscope
patients intubated by using the Macintosh laryngoscope
Device: Macintosh laryngoscope
patients intubated by using the Macintosh laryngoscope




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation [ Time Frame: At baseline, 1 and 5 minutes after tracheal intubation. ]
    During tracheal intubation electrocardiogram is monitorized.

  3. Arrhythmic changes in electrocardiogram during tracheal intubation [ Time Frame: At baseline, 1 and 5 minutes after tracheal intubation. ]
    During tracheal intubation electrocardiogram is monitorized.



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02564640


Locations
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Turkey
Antalya Training and Research Hospital
Antalya, Turkey, 07070
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Study Director: Nilgun Kavrut Ozturk, MD Antalya Training and Research Hospital
Publications of Results:
Other Publications:
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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02564640    
Other Study ID Numbers: AntalyaTRH 008
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: June 2015
Keywords provided by Antalya Training and Research Hospital:
videolaryngoscope
direct laryngoscope
hemodynamic changes
elderly patients