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Hemodynamic Responses of Different Laryngoscopes

11. juni 2015 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

170

Fase

  • Fase 4

Kontakter og lokationer

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Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / 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
Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
Aktiv komparator: McGrath videolaryngoscope
Endotracheal intubation with McGrath videolaryngoscope
Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Arterial blood pressure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of intubation attempts
Tidsramme: During endotracheal intubation
Number of intubation attempts were recorded
During endotracheal intubation
Stylet need
Tidsramme: During endotracheal intubation
Stylet need was recorded
During endotracheal intubation
Cormach-Lehane scales
Tidsramme: During endotracheal intubation
Cormack-Lehane scales were recorded
During endotracheal intubation
Complications
Tidsramme: During endotracheal intubation
Possible complications were recorded
During endotracheal intubation
Sore throat
Tidsramme: Postoperative 2 hours
Possible sore throat was recorded
Postoperative 2 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2014

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

5. juni 2015

Først indsendt, der opfyldte QC-kriterier

8. juni 2015

Først opslået (Skøn)

11. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014/1191

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Kliniske forsøg med Macintosh laryngoscope

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