Clinical trial NCT02564640: Comparison of Hemodynamic Changes by Using the Videolaryngoscope and the Macintosh Laryngoscope
Official title: Comparison of Hemodynamic Changes After Endotracheal Intubation by Using the Videolaryngoscope and the Macintosh Direct Laryngoscope in Elderly Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complication
Keywords: videolaryngoscope
direct laryngoscope
hemodynamic changes
elderly patients
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2015-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Blood pressure changes during tracheal intubation ( mmHg ) ,
timeFrame: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation
Secondary outcomes:
measure: Heart rate changes during tracheal intubation (beats per minute)
timeFrame: At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation
measure: ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation
timeFrame: At baseline, 1 and 5 minutes after tracheal intubation.
measure: Arrhythmic changes in electrocardiogram during tracheal intubation
timeFrame: At baseline, 1 and 5 minutes after tracheal intubation.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Nilgun Kavrut Ozturk, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.
citation: 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.