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Hemodynamic Responses of Different Laryngoscopes

2015년 6월 11일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

170

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Macintosh laryngoscope
Endotracheal intubation with classic (Macintosh) laryngoscope
Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
활성 비교기: Mc-Coy laryngoscope
Endotracheal intubation with Mc-Coy laryngoscope
Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
활성 비교기: C-Mac videolaryngoscope
Endotracheal intubation with C-Mac videolaryngoscope
Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
활성 비교기: McGrath videolaryngoscope
Endotracheal intubation with McGrath videolaryngoscope
Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Arterial blood pressure
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Number of intubation attempts
기간: During endotracheal intubation
Number of intubation attempts were recorded
During endotracheal intubation
Stylet need
기간: During endotracheal intubation
Stylet need was recorded
During endotracheal intubation
Cormach-Lehane scales
기간: During endotracheal intubation
Cormack-Lehane scales were recorded
During endotracheal intubation
Complications
기간: During endotracheal intubation
Possible complications were recorded
During endotracheal intubation
Sore throat
기간: Postoperative 2 hours
Possible sore throat was recorded
Postoperative 2 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 8월 1일

기본 완료 (실제)

2014년 10월 1일

연구 완료 (실제)

2014년 10월 1일

연구 등록 날짜

최초 제출

2015년 6월 5일

QC 기준을 충족하는 최초 제출

2015년 6월 8일

처음 게시됨 (추정)

2015년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 6월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 6월 11일

마지막으로 확인됨

2015년 6월 1일

추가 정보

이 연구와 관련된 용어

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Macintosh laryngoscope에 대한 임상 시험

구독하다