Heart Rate and Rhythm DisordersPhase 4NCT02469363
Hemodynamic Responses of Different Laryngoscopes
A Phase 4 study testing Macintosh laryngoscope, Mc-Coy laryngoscope and C-Mac videolaryngoscope in people with Heart Rate and Rhythm Disorders and Blood Pressures, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate and Rhythm Disorders, Blood Pressures, Oxygen Disorders
- What is being tested?
- Macintosh laryngoscope, Mc-Coy laryngoscope and C-Mac videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2014to Oct 2014
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with ASA I-II status, requiring general anesthesia with endotracheal intubation
Who cannot join
- ASA status higher than II, a history or suspected of difficult airway, hypertansion, under treatment known to affect blood pressure or heart rate (Beta blocker/ Ca-channel blocker), BIS value > 60
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Department of Anesthesiology
Istanbul, 34093
About this study
Official title: Comparison of Different Laryngoscopes in Terms of Hemodynamic Responses
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and techniques have recently started to be used.
In this randomized single blind study, the aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
Read the detailed description
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and methods have recently started to be used.
In this randomized single blind study, our aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
After obtaining Institutional Ethics Committee approval and patient consents, 170 patients (18-65 years old) with ASA I-II status requiring general anesthesia with endotracheal intubation, were enrolled to this prospective randomized study.
Besides routine monitorization (noninvasive blood pressure (NIBP), electrocardiography (ECG), heart rate (HR), peripheral oxygen saturation (SPO2)), continuous BIS monitorization was also performed. Sedation was performed using a standard dose of IV fentanyl (1.5 μg/kg) and midazolam (0.05 mg/kg). Baseline systolic, diastolic and mean arterial blood pressures, HR and SPO2 values were recorded as T0. After a stabilization period of 10 minutes, propofol 2-3 mg/kg IV bolus was applied incrementally until a clinically desirable sedation level was achieved. If necessary, additional propofol boluses were given to maintain a BIS level of 60. As soon as BIS level was reduced to 60, patients were put on 0.6 mg/kg IV rocuronium. 100% oxygen was applied with a facemask for a period of 3 minutes. Then, post induction values (T1) were recorded.
One hundred seventy patients were randomly allocated equally to Macintosh laryngoscope, Mc-Coy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope groups. Endotracheal tube (ETT) of 7.0 mm and 7.5 mm were placed to female and male patients, respectively. All intubation procedures were performed by a single experienced anesthesiologist. Intubation stylet was provided, if necessary. Cuff pressures of endotracheal tubes were standartized to 30 cmH2O via a manometer. The following measurements were recorded immediately after intubation (T2) and at one minute intervals for 5 minutes (T3, T4, T5, T6 and T7).
Moreover; the number of intubation attempts, stylet needs, Cormack-Lehane scales, and the complications occurred during intubation procedures were recorded as the second outcomes. Patients were also questioned for possible sore throat at postoperative 2 hours. Patients requiring more than one attempt to achieve successful intubation were excluded from statistical analysis of data.
- Being tested
- Macintosh laryngoscope, Mc-Coy laryngoscope, C-Mac videolaryngoscope, McGrath videolaryngoscope
- Keywords
- Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope, McGrath videolaryngoscope, Hemodynamic parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
Mc-Coy laryngoscopeDevice
Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
C-Mac videolaryngoscopeDevice
Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
McGrath videolaryngoscopeDevice
Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Endotracheal intubation with classic (Macintosh) laryngoscope Receives: Device: Macintosh laryngoscope |
| Mc-Coy laryngoscope | Active comparator | Endotracheal intubation with Mc-Coy laryngoscope Receives: Device: Mc-Coy laryngoscope |
| C-Mac videolaryngoscope | Active comparator | Endotracheal intubation with C-Mac videolaryngoscope Receives: Device: C-Mac videolaryngoscope |
| McGrath videolaryngoscope | Active comparator | Endotracheal intubation with McGrath videolaryngoscope Receives: Device: McGrath videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood pressure
Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded during and after induction
Measured: Change from baseline in blood pressures at first 20 minutes
Heart rate
Hemodynamic parameters as heart rates were recorded during and after induction
Measured: Change from baseline in heart rates at first 20 minutes
SPO2 value
Hemodynamic parameters as SPO2 values were recorded during and after induction
Measured: Change from baseline in SPO2 values at first 20 minutes
Secondary outcomes (5)
Number of intubation attempts
Number of intubation attempts were recorded
Measured: During endotracheal intubation
Stylet need
Stylet need was recorded
Measured: During endotracheal intubation
Cormach-Lehane scales
Cormack-Lehane scales were recorded
Measured: During endotracheal intubation
Complications
Possible complications were recorded
Measured: During endotracheal intubation
Sore throat
Possible sore throat was recorded
Measured: Postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate and Rhythm DisordersStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Altun, Istanbul University
- Investigators
- Demet Altun, MD, Principal investigator, Istanbul University, Department of Anesthesiology an Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469363
- Sponsor's protocol ID
- 2014/1191
- Status last verified
- Jun 2015
- First submitted
- 5 Jun 2015
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Laryngoscopes in Terms of Hemodynamic Responses
- ClinicalTrials.gov ID
- NCT02469363
- Acronym / sponsor ID
- 2014/1191
- Keywords
- Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope, McGrath videolaryngoscope, Hemodynamic parameters
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Jun 2015 (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.
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and techniques have recently started to be used.
In this randomized single blind study, the aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
Detailed description
During laryngoscopy and endotracheal intubation, stimulation of supraglottic regions leads to an increase in the plasma catecholamine concentrations due to the activation of the sympatho-adrenal system. Prevention or reduction of this increment is important for hemodynamic control. Therefore, various methods such as providing adequate depth of anesthesia and shortening the time of laryngoscopy were used. On the other hand; alternative laryngoscopy devices and methods have recently started to be used.
In this randomized single blind study, our aim is to compare the hemodynamic responses of four different laryngoscopy techniques with Macintosh laryngoscope, McCoy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope in patients with normal predictive airway.
After obtaining Institutional Ethics Committee approval and patient consents, 170 patients (18-65 years old) with ASA I-II status requiring general anesthesia with endotracheal intubation, were enrolled to this prospective randomized study.
Besides routine monitorization (noninvasive blood pressure (NIBP), electrocardiography (ECG), heart rate (HR), peripheral oxygen saturation (SPO2)), continuous BIS monitorization was also performed. Sedation was performed using a standard dose of IV fentanyl (1.5 μg/kg) and midazolam (0.05 mg/kg). Baseline systolic, diastolic and mean arterial blood pressures, HR and SPO2 values were recorded as T0. After a stabilization period of 10 minutes, propofol 2-3 mg/kg IV bolus was applied incrementally until a clinically desirable sedation level was achieved. If necessary, additional propofol boluses were given to maintain a BIS level of 60. As soon as BIS level was reduced to 60, patients were put on 0.6 mg/kg IV rocuronium. 100% oxygen was applied with a facemask for a period of 3 minutes. Then, post induction values (T1) were recorded.
One hundred seventy patients were randomly allocated equally to Macintosh laryngoscope, Mc-Coy laryngoscope, C-Mac videolaryngoscope and McGrath videolaryngoscope groups. Endotracheal tube (ETT) of 7.0 mm and 7.5 mm were placed to female and male patients, respectively. All intubation procedures were performed by a single experienced anesthesiologist. Intubation stylet was provided, if necessary. Cuff pressures of endotracheal tubes were standartized to 30 cmH2O via a manometer. The following measurements were recorded immediately after intubation (T2) and at one minute intervals for 5 minutes (T3, T4, T5, T6 and T7).
Moreover; the number of intubation attempts, stylet needs, Cormack-Lehane scales, and the complications occurred during intubation procedures were recorded as the second outcomes. Patients were also questioned for possible sore throat at postoperative 2 hours. Patients requiring more than one attempt to achieve successful intubation were excluded from statistical analysis of data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Device: Macintosh laryngoscopeEndotracheal intubation with classic (Macintosh) laryngoscope |
| Mc-Coy laryngoscope | Active comparator | Device: Mc-Coy laryngoscopeEndotracheal intubation with Mc-Coy laryngoscope |
| C-Mac videolaryngoscope | Active comparator | Device: C-Mac videolaryngoscopeEndotracheal intubation with C-Mac videolaryngoscope |
| McGrath videolaryngoscope | Active comparator | Device: McGrath videolaryngoscopeEndotracheal intubation with McGrath videolaryngoscope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ASA I-II status, requiring general anesthesia with endotracheal intubation
Key exclusion criteria (1 listed)
- ASA status higher than II, a history or suspected of difficult airway, hypertansion, under treatment known to affect blood pressure or heart rate (Beta blocker/ Ca-channel blocker), BIS value > 60
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 laryngoscopeHemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh) | Device | Macintosh laryngoscope |
| Mc-Coy laryngoscopeHemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope | Device | Mc-Coy laryngoscope |
| C-Mac videolaryngoscopeHemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope | Device | C-Mac videolaryngoscope |
| McGrath videolaryngoscopeHemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope | Device | McGrath videolaryngoscope |
Primary outcome
Arterial blood pressure
Time frame: Change from baseline in blood pressures at first 20 minutes
Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded during and after induction
Heart rate
Time frame: Change from baseline in heart rates at first 20 minutes
Hemodynamic parameters as heart rates were recorded during and after induction
SPO2 value
Time frame: Change from baseline in SPO2 values at first 20 minutes
Hemodynamic parameters as SPO2 values were recorded during and after induction
5 secondary outcomes
Number of intubation attempts
Time frame: During endotracheal intubation
Stylet need
Time frame: During endotracheal intubation
Cormach-Lehane scales
Time frame: During endotracheal intubation
Complications
Time frame: During endotracheal intubation
Sore throat
Time frame: Postoperative 2 hours
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 12 Jun 2015.
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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.
Demet Altun, MD principal investigator
Istanbul University, Department of Anesthesiology an Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Macintosh laryngoscope, Mc-Coy laryngoscope and C-Mac videolaryngoscope in people with Heart Rate and Rhythm Disorders and Blood Pressures, run by Istanbul 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 1 inclusion and 1 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 12 Jun 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Arterial blood pressure (time frame: Change from baseline in blood pressures at first 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2015.