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Hemodynamic Responses of Different Laryngoscopes

11. Juni 2015 aktualisiert von: Demet Altun, Istanbul University

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

170

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Istanbul, Truthahn, 34093
        • Istanbul University, Department of anesthesiology

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Macintosh laryngoscope
Endotracheal intubation with classic (Macintosh) laryngoscope
Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
Aktiver Komparator: Mc-Coy laryngoscope
Endotracheal intubation with Mc-Coy laryngoscope
Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
Aktiver Komparator: C-Mac videolaryngoscope
Endotracheal intubation with C-Mac videolaryngoscope
Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
Aktiver Komparator: McGrath videolaryngoscope
Endotracheal intubation with McGrath videolaryngoscope
Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Arterial blood pressure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of intubation attempts
Zeitfenster: During endotracheal intubation
Number of intubation attempts were recorded
During endotracheal intubation
Stylet need
Zeitfenster: During endotracheal intubation
Stylet need was recorded
During endotracheal intubation
Cormach-Lehane scales
Zeitfenster: During endotracheal intubation
Cormack-Lehane scales were recorded
During endotracheal intubation
Complications
Zeitfenster: During endotracheal intubation
Possible complications were recorded
During endotracheal intubation
Sore throat
Zeitfenster: Postoperative 2 hours
Possible sore throat was recorded
Postoperative 2 hours

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Demet Altun, MD, Istanbul University, Department of Anesthesiology an Reanimation

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2014

Primärer Abschluss (Tatsächlich)

1. Oktober 2014

Studienabschluss (Tatsächlich)

1. Oktober 2014

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2015

Zuerst gepostet (Schätzen)

11. Juni 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

12. Juni 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juni 2015

Zuletzt verifiziert

1. Juni 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2014/1191

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