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

NCT03376828 | Completed

• 1 other identifier: 2016/855
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation; Anesthesia; Hypertension

Keywords

laryngoscopy; videolaryngoscopy; hypertension

Outcome Measures

Primary Outcomes (1)

• Hemodynamic response

  Change from baseline noninvasive blood pressure and heart rate

  0-10 minute

Secondary Outcomes (2)

• intubation time

  0-120 seconds

• Glottic view grade

  During intubation

Study Arms (4)

Hypertensive T group

ACTIVE COMPARATOR

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

Hypertensive VL group

ACTIVE COMPARATOR

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

Non-hypertensive T group

SHAM COMPARATOR

Non-hypertensive T group: (Preoperative systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 100 mmHg) Macintosh laryngoscopy using intubated

Device: Macintosh laryngoscopy

Non-hypertensive VL group

SHAM COMPARATOR

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

Interventions

Macintosh laryngoscopy DEVICE

Endotracheal intubation time using the Macintosh laryngoscope

Hypertensive T group; Non-hypertensive T group

C-Mac Videolaryngoscope DEVICE

Endotracheal intubation time using the C-Mac Videolaryngoscope

Hypertensive VL group; Non-hypertensive VL group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Training and Research Hospital

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 12598280 BACKGROUND

• 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.

  PMID: 26072085 BACKGROUND

• 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.

  PMID: 26379966 BACKGROUND

• 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.

  PMID: 8678248 BACKGROUND

• 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.

  PMID: 25886716 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 19, 2017
• Study Start: May 25, 2016
• Primary Completion: May 25, 2018
• Study Completion: May 25, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

TU (1)