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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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 groups in NCT02469363
Study groupRoleWhat they receive
Macintosh laryngoscopeActive comparatorEndotracheal intubation with classic (Macintosh) laryngoscope
Receives: Device: Macintosh laryngoscope
Mc-Coy laryngoscopeActive comparatorEndotracheal intubation with Mc-Coy laryngoscope
Receives: Device: Mc-Coy laryngoscope
C-Mac videolaryngoscopeActive comparatorEndotracheal intubation with C-Mac videolaryngoscope
Receives: Device: C-Mac videolaryngoscope
McGrath videolaryngoscopeActive comparatorEndotracheal 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.

  1. 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

  2. Heart rate

    Hemodynamic parameters as heart rates were recorded during and after induction

    Measured: Change from baseline in heart rates at first 20 minutes

  3. 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)
  1. Number of intubation attempts

    Number of intubation attempts were recorded

    Measured: During endotracheal intubation

  2. Stylet need

    Stylet need was recorded

    Measured: During endotracheal intubation

  3. Cormach-Lehane scales

    Cormack-Lehane scales were recorded

    Measured: During endotracheal intubation

  4. Complications

    Possible complications were recorded

    Measured: During endotracheal intubation

  5. 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.

  1. First posted11 Jun 2015 (estimated)
  2. Study startAug 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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)
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

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.

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