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

Comparison of Hemodynamic Changes After Endotracheal Intubation by Using the Videolaryngoscope and the Macintosh Direct Laryngoscope in Elderly Hypertensive Patients

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complication
• Intervention / Treatment: Device: videolaryngoscope; Device: Macintosh laryngoscope

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07070
    • Antalya Training And Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure changes during tracheal intubation ( mmHg ) ,	At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate changes during tracheal intubation (beats per minute)		At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation
ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation	During tracheal intubation electrocardiogram is monitorized.	At baseline, 1 and 5 minutes after tracheal intubation.
Arrhythmic changes in electrocardiogram during tracheal intubation	During tracheal intubation electrocardiogram is monitorized.	At baseline, 1 and 5 minutes after tracheal intubation.

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Nilgun Kavrut Ozturk, MD, Antalya Training And Research Hospital

Publications and helpful links

General Publications

• Kihara S, Brimacombe J, Yaguchi Y, Watanabe S, Taguchi N, Komatsuzaki T. Hemodynamic responses among three tracheal intubation devices in normotensive and hypertensive patients. Anesth Analg. 2003 Mar;96(3):890-895. doi: 10.1213/01.ANE.0000048706.15720.C9.
• Kanaide M, Fukusaki M, Tamura S, Takada M, Miyako M, Sumikawa K. Hemodynamic and catecholamine responses during tracheal intubation using a lightwand device (Trachlight) in elderly patients with hypertension. J Anesth. 2003;17(3):161-5. doi: 10.1007/s00540-003-0166-8.
• 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.
• Xue FS, Zhang GH, Li XY, Sun HT, Li P, Sun HY, Xu YC, Liu Y. Comparison of haemodynamic responses to orotracheal intubation with GlideScope videolaryngoscope and fibreoptic bronchoscope. Eur J Anaesthesiol. 2006 Jun;23(6):522-6. doi: 10.1017/S0265021506000299. Epub 2006 Mar 1.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: elderly patients; videolaryngoscope; direct laryngoscope; hemodynamic changes
• Other Study ID Numbers: AntalyaTRH 008