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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03376828
Other study ID # 2016/855
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2016
Est. completion date May 25, 2018

Study information

Verified date December 2018
Source Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 25, 2018
Est. primary completion date May 25, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Macintosh laryngoscopy
Endotracheal intubation time using the Macintosh laryngoscope
C-Mac Videolaryngoscope
Endotracheal intubation time using the C-Mac Videolaryngoscope

Locations

Country Name City State
Turkey Adnan Menderes University Training and Research Hospital Aydin

Sponsors (1)

Lead Sponsor Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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):890-5, table of contents. — View Citation

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. — View Citation

Sarkilar G, Sargin M, Saritas TB, Borazan H, Gök F, Kiliçaslan 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamic response Change from baseline noninvasive blood pressure and heart rate 0-10 minute
Secondary intubation time The time elapsed between the passage of the laryngoscopy through the teeth to teeth 0-120 seconds
Secondary Glottic view grade Using the Cormack Lehane score During intubation
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