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

Not Applicable

Completed

• Conditions: Anesthesia Intubation Complication
• Interventions: Device: videolaryngoscope; Device: Macintosh laryngoscope

• Registration Number: NCT02564640
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2015-06
• Study Start: 2015-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
videolaryngoscope	videolaryngoscope	patients intubated by using the videolaryngoscopy
Macintosh laryngoscope	Macintosh laryngoscope	patients intubated by using the Macintosh laryngoscope

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
ST segment elevation in electrocardiogram indicating myocardial ischaemia during tracheal intubation	At baseline, 1 and 5 minutes after tracheal intubation.	During tracheal intubation electrocardiogram is monitorized.
Arrhythmic changes in electrocardiogram during tracheal intubation	At baseline, 1 and 5 minutes after tracheal intubation.	During tracheal intubation electrocardiogram is monitorized.
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

Trial Locations

Locations (1)

Antalya Training and Research Hospital; 🇹🇷 Antalya, Turkey