- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02469363
Hemodynamic Responses of Different Laryngoscopes
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
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Istanbul, Kalkon, 34093
- Istanbul University, Department of Anesthesiology
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients with ASA I-II status, requiring general anesthesia with endotracheal intubation
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Macintosh laryngoscope
Endotracheal intubation with classic (Macintosh) laryngoscope
|
Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
|
Aktiv komparator: Mc-Coy laryngoscope
Endotracheal intubation with Mc-Coy laryngoscope
|
Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
|
Aktiv komparator: C-Mac videolaryngoscope
Endotracheal intubation with C-Mac videolaryngoscope
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Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
|
Aktiv komparator: McGrath videolaryngoscope
Endotracheal intubation with McGrath videolaryngoscope
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Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Arterial blood pressure
Tidsram: 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
|
Change from baseline in blood pressures at first 20 minutes
|
Heart rate
Tidsram: Change from baseline in heart rates at first 20 minutes
|
Hemodynamic parameters as heart rates were recorded during and after induction
|
Change from baseline in heart rates at first 20 minutes
|
SPO2 value
Tidsram: Change from baseline in SPO2 values at first 20 minutes
|
Hemodynamic parameters as SPO2 values were recorded during and after induction
|
Change from baseline in SPO2 values at first 20 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of intubation attempts
Tidsram: During endotracheal intubation
|
Number of intubation attempts were recorded
|
During endotracheal intubation
|
Stylet need
Tidsram: During endotracheal intubation
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Stylet need was recorded
|
During endotracheal intubation
|
Cormach-Lehane scales
Tidsram: During endotracheal intubation
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Cormack-Lehane scales were recorded
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During endotracheal intubation
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Complications
Tidsram: During endotracheal intubation
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Possible complications were recorded
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During endotracheal intubation
|
Sore throat
Tidsram: Postoperative 2 hours
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Possible sore throat was recorded
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Postoperative 2 hours
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Demet Altun, MD, Istanbul University, Department of Anesthesiology an Reanimation
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014/1191
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