IntubationLaryngoscopyNCT03376828
The Effect of Video and Traditional Laryngoscopy on Hemodynamic Response in Hypertensive and Normotensive Patients
A study testing Macintosh laryngoscopy and C-Mac Videolaryngoscope in people with Intubation and Anesthesia, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Anesthesia, Hypertension
- What is being tested?
- Macintosh laryngoscopy and C-Mac Videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2016to 25 May 2018
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-75 years.
- Underwent surgery under general anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Training and Research Hospital
Aydin, 09100
About this study
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.
Read the detailed 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
- Conditions
- Intubation, Anesthesia, Hypertension
- Being tested
- Macintosh laryngoscopy, C-Mac Videolaryngoscope
- Keywords
- laryngoscopy, videolaryngoscopy, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopyDevice
Endotracheal intubation time using the Macintosh laryngoscope
C-Mac VideolaryngoscopeDevice
Endotracheal intubation time using the C-Mac Videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: C-Mac Videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic response
Change from baseline noninvasive blood pressure and heart rate
Measured: 0-10 minute
Secondary outcomes (2)
intubation time
The time elapsed between the passage of the laryngoscopy through the teeth to teeth
Measured: 0-120 seconds
Glottic view grade
Using the Cormack Lehane score
Measured: During intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start25 May 2016
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SİNAN YILMAZ, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376828
- Sponsor's protocol ID
- 2016/855
- Acronym
- Laryngoscopy
- Status last verified
- Dec 2018
- First submitted
- 6 Dec 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12598280Abdelgawad 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.
PubMed 26072085Sarkilar 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.
PubMed 26379966McCoy 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.
PubMed 8678248Hossfeld 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.
PubMed 25886716
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video and Traditional Laryngoscopy on Hemodynamic Response in Hypertensive and Normotensive Patients
- ClinicalTrials.gov ID
- NCT03376828
- Acronym / sponsor ID
- Laryngoscopy / 2016/855
- Conditions
- Intubation, Anesthesia, Hypertension
- Keywords
- laryngoscopy, videolaryngoscopy, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 25 May 2016 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 19 Dec 2017 (actual)
- 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.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Hypertensive T group | Active comparator | Device: Macintosh laryngoscopyHypertensive 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 |
| Hypertensive VL group | Active comparator | Device: C-Mac VideolaryngoscopeHypertensive 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 |
| Non-hypertensive T group | Sham comparator | Device: Macintosh laryngoscopyNon-hypertensive T group: (Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg) Macintosh laryngoscopy using intubated |
| Non-hypertensive VL group | Sham comparator | Device: C-Mac VideolaryngoscopeNon-hypertensive VL group: Preoperative systolic blood pressure < 140 mmHg and diastolic blood pressure < 100 mmHg C-Mac Videolaryngoscope using intubated |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-75 years.
- Underwent surgery under general anesthesia.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Macintosh laryngoscopyEndotracheal intubation time using the Macintosh laryngoscope | Device | Hypertensive T group, Non-hypertensive T group |
| C-Mac VideolaryngoscopeEndotracheal intubation time using the C-Mac Videolaryngoscope | Device | Hypertensive VL group, Non-hypertensive VL group |
Primary outcome
Hemodynamic response
Time frame: 0-10 minute
Change from baseline noninvasive blood pressure and heart rate
2 secondary outcomes
intubation time
Time frame: 0-120 seconds
Glottic view grade
Time frame: During intubation
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 26 Dec 2018.
- Background: PubMed 12598280Kihara 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.
- Background: PubMed 26072085Abdelgawad 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.
- Background: PubMed 26379966Sarkilar 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.
- Background: PubMed 8678248McCoy 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.
- Background: PubMed 25886716Hossfeld 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscopy and C-Mac Videolaryngoscope in people with Intubation and Anesthesia, run by Aydin Adnan Menderes University 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 26 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
Hemodynamic response (time frame: 0-10 minute). 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 NCT03376828, which also lists 5 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 26 Dec 2018.