The Effect of Video and Traditional Laryngoscopy on Hemodynamic Response in Hypertensive and Normotensive Patients (Laryngoscopy)

During endotracheal intubation, it is known that la laryngoscopy has significant effects, such as tachycardia and blood pressure increase, which may be harmful, especially in those with cardiovascular disease. Different studies comparing laryngeal stimulation and there resulting hemodynamic response made with various intubation devices are available in the literature. The investigators planned to work with the hypothesis that endotracheal intubation with videolaryngoscopy would have less hemodynamic response traditional (Macintosh) laryngoscopy and the use of videolaryngoscopy would result in wider vision with less laryngeal stimulation.

Study Overview

• Status: Completed
• Conditions: Hypertension; Intubation; Anesthesia
• Intervention / Treatment: Device: Macintosh laryngoscopy; Device: C-Mac Videolaryngoscope

Detailed Description

In this study, in a study on endotracheal intubation under general anesthesia, a routine preparation of endotracheal intubation using video laryngoscopy or Macintosh laryngoscopy in adult hypertensive and normotensive patients between 18-75 years old, form will be written and recorded.

Patient age, weight, height, sex, operation, co-morbid conditions and vital findings, measurements used in airway evaluation, initial trial success, laryngoscope using number of procedures, intubation tube number will be recorded.

Statistical analysis was performed using statistical program to compare the hemodynamic response of hypertensive and normotensive patients using videolaryngoscope or Macintosh laryngoscope

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Adnan Menderes University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18-75 years.
• Underwent surgery under general anesthesia.

Exclusion Criteria:

• ASA (American Society of Anesthesiologists) IV, V patients
• Preoperative systolic blood pressure 180 mmHg, diastolic blood pressure a pressure above 110 mmHg.
• Ejection fraction is less than 40%.
• Difficult intubation history
• Mallampati 3,4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hypertensive T group; Hypertensive T group: Patients participating in the study were randomly assigned hypertensive (preoperative systolic blood pressure <180 mmHg and diastolic blood pressure <100 mmHg) Macintosh laryngoscopy using intubated	Device: Macintosh laryngoscopy; Endotracheal intubation time using the Macintosh laryngoscope
Active Comparator: Hypertensive VL group; Hypertensive VL group: Patients participating in the study were randomly assigned hypertensive (preoperative systolic blood pressure <180 mmHg and diastolic blood pressure <100 mmHg) C-Mac Videolaryngoscope using intubated	Device: C-Mac Videolaryngoscope; Endotracheal intubation time using the C-Mac Videolaryngoscope
Sham Comparator: Non-hypertensive T group; Non-hypertensive T group: (Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg) Macintosh laryngoscopy using intubated	Device: Macintosh laryngoscopy; Endotracheal intubation time using the Macintosh laryngoscope
Sham Comparator: Non-hypertensive VL group; Non-hypertensive VL group: Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg C-Mac Videolaryngoscope using intubated	Device: C-Mac Videolaryngoscope; Endotracheal intubation time using the C-Mac Videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic response	Change from baseline noninvasive blood pressure and heart rate	0-10 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubation time	The time elapsed between the passage of the laryngoscopy through the teeth to teeth	0-120 seconds
Glottic view grade	Using the Cormack Lehane score	During intubation

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Publications and helpful links

General Publications

• Abdelgawad AF, Shi QF, Halawa MA, Wu ZL, Wu ZY, Chen XD, Yao SL. Comparison of cardiac output and hemodynamic responses of intubation among different videolaryngoscopies in normotensive and hypertensive patients. J Huazhong Univ Sci Technolog Med Sci. 2015 Jun;35(3):432-438. doi: 10.1007/s11596-015-1449-7. Epub 2015 Jun 14.
• Hossfeld B, Frey K, Doerges V, Lampl L, Helm M. Improvement in glottic visualisation by using the C-MAC PM video laryngoscope as a first-line device for out-of-hospital emergency tracheal intubation: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):425-31. doi: 10.1097/EJA.0000000000000249.
• 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.
• Sarkilar G, Sargin M, Saritas TB, Borazan H, Gok F, Kilicaslan A, Otelcioglu S. Hemodynamic responses to endotracheal intubation performed with video and direct laryngoscopy in patients scheduled for major cardiac surgery. Int J Clin Exp Med. 2015 Jul 15;8(7):11477-83. eCollection 2015.
• McCoy EP, Mirakhur RK, McCloskey BV. A comparison of the stress response to laryngoscopy. The Macintosh versus the McCoy blade. Anaesthesia. 1995 Nov;50(11):943-6. doi: 10.1111/j.1365-2044.1995.tb05924.x.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2016
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): May 25, 2018

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 24, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: hypertension; laryngoscopy; videolaryngoscopy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2016/855

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No