Blood PressureNCT02708420
Does Glidescope Video Laryngoscope is Related to Less Hemodynamic Response?
A study testing Glidescope and Macintosh Laryngoscope in people with Blood Pressure, run by Gata Haydarpasa Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Glidescope and Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical Status 2-3
- Patients undergoing elective cardiac bypass surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
GATA Haydarpasa Training Hospital
Istanbul, Asia, 34668
About this study
Official title: Comparison of Hemodynamic Responses to Endotracheal Intubation With Glidescope Video Laryngoscope and Macintosh Direct Laryngoscope in Patients Undergoing Coronary Artery Bypass Surgery
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.
Read the detailed 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.
- Conditions
- Blood Pressure
- Being tested
- Glidescope, Macintosh Laryngoscope
- Keywords
- Glidescope, Cardiovascular surgery, Macintosh Laryngoscope, Hemodynamic response, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlidescopeDevice
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 LaryngoscopeDevice
This technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Glidescope intubation | Other | 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. Receives: Device: Glidescope |
| Macintosh Laryngoscope | Other | This standard technique involves laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved. Receives: Device: Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
invasive blood pressure (mmHg) monitoring
Measured: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Change in heart rate
Heart rate (beats per minute) will be measured before induction, and throughout and after laryngoscopy
Measured: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Change in diastolic blood pressure
invasive blood pressure (mmHg) monitoring
Measured: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Change in mean arterial pressure
invasive blood pressure (mmHg) monitoring
Measured: 5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Secondary outcomes (2)
Procedure time
Total laryngoscopy and intubation time (minutes)
Measured: 10 minutes
Cormack lehane laryngoscopic view will be recorded
laryngoscopic view data will be recorded according to Cormack Lehane scale (A Scale with 1-4)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Jan 2016
- Primary completion18 May 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gata Haydarpasa Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sezai Ozkan, Prof., Study chair, Gata Haydarpasa Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708420
- Sponsor's protocol ID
- GataHRH
- Status last verified
- Mar 2016
- First submitted
- 27 Feb 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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. No abstract available.
PubMed 26760401Amini S, Shakib M. Hemodynamic changes following endotracheal intubation in patients undergoing cesarean section with general anesthesia: application of glidescope(R) videolaryngoscope versus direct laryngoscope. Anesth Pain Med. 2015 Mar 30;5(2):e21836. doi: 10.5812/aapm.21836. eCollection 2015 Apr.
PubMed 25866708Dashti M, Amini S, Azarfarin R, Totonchi Z, Hatami M. Hemodynamic changes following endotracheal intubation with glidescope((R)) video-laryngoscope in patients with untreated hypertension. Res Cardiovasc Med. 2014 May;3(2):e17598. doi: 10.5812/cardiovascmed.17598. Epub 2014 Apr 1.
PubMed 25478537Aqil 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.
PubMed 25225515Pournajafian 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.
PubMed 24910788Maassen 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.
PubMed 23610856Siddiqui 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.
PubMed 19417675Xue 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. doi: 10.1016/j.jclinane.2006.11.004.
PubMed 17572317Russell T, Khan S, Elman J, Katznelson R, Cooper RM. Measurement of forces applied during Macintosh direct laryngoscopy compared with GlideScope(R) videolaryngoscopy. Anaesthesia. 2012 Jun;67(6):626-31. doi: 10.1111/j.1365-2044.2012.07087.x. Epub 2012 Feb 21.
PubMed 22352799
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Responses to Endotracheal Intubation With Glidescope Video Laryngoscope and Macintosh Direct Laryngoscope in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT02708420
- Acronym / sponsor ID
- GataHRH
- Conditions
- Blood Pressure
- Keywords
- Glidescope, Cardiovascular surgery, Macintosh Laryngoscope, Hemodynamic response, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gata Haydarpasa Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glidescope intubation | Other | Device: GlidescopeThis 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 | Other | Device: Macintosh LaryngoscopeThis standard technique involves laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical Status 2-3
- Patients undergoing elective cardiac bypass surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlidescopeThis 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. | Device | Glidescope intubation |
| Macintosh LaryngoscopeThis technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved. | Device | Macintosh Laryngoscope |
Primary outcome
Change in systolic blood pressure
Time frame: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
invasive blood pressure (mmHg) monitoring
Change in heart rate
Time frame: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
Heart rate (beats per minute) will be measured before induction, and throughout and after laryngoscopy
Change in diastolic blood pressure
Time frame: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
invasive blood pressure (mmHg) monitoring
Change in mean arterial pressure
Time frame: 5 minutes;At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes
invasive blood pressure (mmHg) monitoring
2 secondary outcomes
Procedure time
Time frame: 10 minutes
Cormack lehane laryngoscopic view will be recorded
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Background: PubMed 26760401Friedman 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. No abstract available.
- Background: PubMed 25866708Amini S, Shakib M. Hemodynamic changes following endotracheal intubation in patients undergoing cesarean section with general anesthesia: application of glidescope(R) videolaryngoscope versus direct laryngoscope. Anesth Pain Med. 2015 Mar 30;5(2):e21836. doi: 10.5812/aapm.21836. eCollection 2015 Apr.
- Background: PubMed 25478537Dashti M, Amini S, Azarfarin R, Totonchi Z, Hatami M. Hemodynamic changes following endotracheal intubation with glidescope((R)) video-laryngoscope in patients with untreated hypertension. Res Cardiovasc Med. 2014 May;3(2):e17598. doi: 10.5812/cardiovascmed.17598. Epub 2014 Apr 1.
- Background: PubMed 25225515Aqil 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.
- Background: PubMed 24910788Pournajafian 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.
- Background: PubMed 23610856Maassen 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.
- Background: PubMed 19417675Siddiqui 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.
- Background: PubMed 17572317Xue 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. doi: 10.1016/j.jclinane.2006.11.004.
- Background: PubMed 22352799Russell T, Khan S, Elman J, Katznelson R, Cooper RM. Measurement of forces applied during Macintosh direct laryngoscopy compared with GlideScope(R) videolaryngoscopy. Anaesthesia. 2012 Jun;67(6):626-31. doi: 10.1111/j.1365-2044.2012.07087.x. Epub 2012 Feb 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sezai Ozkan, Prof. study chair
Gata Haydarpasa Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glidescope and Macintosh Laryngoscope in people with Blood Pressure, run by Gata Haydarpasa Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: 5 minutes; At start of laryngoscopy and after 30th seconds, 60th seconds, 90th seconds, 120th seconds, 3rd minutes, 4th minutes, 5th minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708420, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.