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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02708420
Other study ID # GataHRH
Secondary ID
Status Completed
Phase N/A
First received February 27, 2016
Last updated June 12, 2017
Start date January 1, 2016
Est. completion date June 1, 2017

Study information

Verified date March 2016
Source Gata Haydarpasa Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients.


Description:

Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients. After induction with our institutional protocol for cardiac bypass surgery, hemodynamic data including heart rate, systolic and diastolic arterial pressure data will be recorded. Time for intubation, age, sex, ASA status data will also be recorded.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 1, 2017
Est. primary completion date May 18, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) physical Status 2-3

- Patients undergoing elective cardiac bypass surgery

Exclusion Criteria:

- Difficult intubation history

- Need for Rapid sequence intubation or alternative intubation method

- Emergency procedures

- Patients that have predictive factors for difficult intubation

- Patients with permanent pacemaker

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Glidescope
This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
Macintosh Laryngoscope
This technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.

Locations

Country Name City State
Turkey GATA Haydarpasa Training Hospital I?stanbul Asia

Sponsors (1)

Lead Sponsor Collaborator
Gata Haydarpasa Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Amini S, Shakib M. Hemodynamic changes following endotracheal intubation in patients undergoing cesarean section with general anesthesia: application of glidescope® videolaryngoscope versus direct laryngoscope. Anesth Pain Med. 2015 Mar 30;5(2):e21836. doi: 10.5812/aapm.21836. eCollection 2015 Apr. — View Citation

Aqil M. A study of stress response to endotracheal intubation comparing glidescope and flexible fiberoptic bronchoscope. Pak J Med Sci. 2014 Sep;30(5):1001-6. doi: 10.12669/pjms.305.4788. — View Citation

Dashti M, Amini S, Azarfarin R, Totonchi Z, Hatami M. Hemodynamic changes following endotracheal intubation with glidescope(®) video-laryngoscope in patients with untreated hypertension. Res Cardiovasc Med. 2014 May;3(2):e17598. doi: 10.5812/cardiovascmed.17598. Epub 2014 Apr 1. — View Citation

Friedman Z, Gurevich L, Siddiqui N. The effect of a modified GlideScope intubation technique on procedure times, airway morbidity and haemodynamic response. Eur J Anaesthesiol. 2016 Mar;33(3):229-30. doi: 10.1097/EJA.0000000000000339. — View Citation

Maassen RL, Pieters BM, Maathuis B, Serroyen J, Marcus MA, Wouters P, van Zundert AA. Endotracheal intubation using videolaryngoscopy causes less cardiovascular response compared to classic direct laryngoscopy, in cardiac patients according a standard hospital protocol. Acta Anaesthesiol Belg. 2012;63(4):181-6. — View Citation

Pournajafian AR, Ghodraty MR, Faiz SH, Rahimzadeh P, Goodarzynejad H, Dogmehchi E. Comparing GlideScope Video Laryngoscope and Macintosh Laryngoscope Regarding Hemodynamic Responses During Orotracheal Intubation: A Randomized Controlled Trial. Iran Red Crescent Med J. 2014 Apr;16(4):e12334. doi: 10.5812/ircmj.12334. Epub 2014 Apr 5. — View Citation

Russell T, Khan S, Elman J, Katznelson R, Cooper RM. Measurement of forces applied during Macintosh direct laryngoscopy compared with GlideScope® videolaryngoscopy. Anaesthesia. 2012 Jun;67(6):626-31. doi: 10.1111/j.1365-2044.2012.07087.x. Epub 2012 Feb 21. — View Citation

Siddiqui N, Katznelson R, Friedman Z. Heart rate/blood pressure response and airway morbidity following tracheal intubation with direct laryngoscopy, GlideScope and Trachlight: a randomized control trial. Eur J Anaesthesiol. 2009 Sep;26(9):740-5. doi: 10.1097/EJA.0b013e32832b138d. — View Citation

Xue FS, Zhang GH, Li XY, Sun HT, Li P, Li CW, Liu KP. Comparison of hemodynamic responses to orotracheal intubation with the GlideScope videolaryngoscope and the Macintosh direct laryngoscope. J Clin Anesth. 2007 Jun;19(4):245-50. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in systolic blood pressure invasive blood pressure (mmHg) monitoring 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Primary Change in heart rate Heart rate (beats per minute) will be measured before induction, and throughout and after laryngoscopy 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Primary Change in diastolic blood pressure invasive blood pressure (mmHg) monitoring 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Primary Change in mean arterial pressure invasive blood pressure (mmHg) monitoring 5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Secondary Procedure time Total laryngoscopy and intubation time (minutes) 10 minutes
Secondary Cormack lehane laryngoscopic view will be recorded laryngoscopic view data will be recorded according to Cormack Lehane scale (A Scale with 1-4) 10 minutes
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