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

Anesthesia Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02564640
• Other study ID #: AntalyaTRH 008
• Status: Completed
• Phase: N/A
• First received: September 28, 2015
• Last updated: December 8, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia Intubation Complication

Intervention

Device:
• videolaryngoscope
patients intubated by using the videolaryngoscope
• Macintosh laryngoscope
patients intubated by using the Macintosh laryngoscope

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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):890-5, table of contents. — View 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. — View 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. Epub 2006 Mar 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure changes during tracheal intubation ( mmHg ) ,		At baseline, 1 minute before intubation, and 1,2,3,4 and 5 minutes after tracheal intubation	No
Secondary	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	No
Secondary	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.	No
Secondary	Arrhythmic changes in electrocardiogram during tracheal intubation	During tracheal intubation electrocardiogram is monitorized.	At baseline, 1 and 5 minutes after tracheal intubation.	No