Skip to main content
OpenTrials
Completed

NCT Number: NCT02564640

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Intubation Complication

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital

Antalya, 07070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videolaryngoscope

Device

patients intubated by using the videolaryngoscope

Macintosh laryngoscope

Device

patients intubated by using the Macintosh laryngoscope

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2015
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.