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

NCT ID: NCT03376828

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-25

Study Completion Date

2018-05-25

Brief Summary

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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.

Detailed Description

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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

Conditions

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Intubation Anesthesia Hypertension

Keywords

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laryngoscopy videolaryngoscopy hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Macintosh laryngoscopy

Intervention Type DEVICE

Endotracheal intubation time using the Macintosh laryngoscope

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

Group Type ACTIVE_COMPARATOR

C-Mac Videolaryngoscope

Intervention Type DEVICE

Endotracheal intubation time using the C-Mac Videolaryngoscope

Non-hypertensive T group

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

Group Type SHAM_COMPARATOR

Macintosh laryngoscopy

Intervention Type DEVICE

Endotracheal intubation time using the Macintosh laryngoscope

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

Group Type SHAM_COMPARATOR

C-Mac Videolaryngoscope

Intervention Type DEVICE

Endotracheal intubation time using the C-Mac Videolaryngoscope

Interventions

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Macintosh laryngoscopy

Endotracheal intubation time using the Macintosh laryngoscope

Intervention Type DEVICE

C-Mac Videolaryngoscope

Endotracheal intubation time using the C-Mac Videolaryngoscope

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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SİNAN YILMAZ

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adnan Menderes University Training and Research Hospital

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 12598280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26072085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26379966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8678248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25886716 (View on PubMed)

Other Identifiers

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2016/855

Identifier Type: -

Identifier Source: org_study_id