Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation
Evaluation of Adequacy of Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure for Pressure-controlled Mask Ventilation During Induction of Anesthesia: a Randomized Controlled Study
Pulmonary aspiration of gastric contents is one of the leading causes of general anesthesia-related mortality. Gastric insufflation during positive pressure mask ventilation increases the gastric volume, and consequently the risk of regurgitation. Thus, positive pressure mask ventilation should be avoided during rapid sequence induction of anesthesia when full-stomach is suspected (e.g. inadequate fasting hours, gastrointestinal obstruction, delayed gastric emptying, and lower esophageal disease) Although avoidance of positive pressure mask ventilation during induction would potentially minimize the risk of aspiration, this would lead to rapid hypoxia . Hence, finding a proper regimen for mask ventilation would avoid hypoxia which might be serious in high-risk patients.
Pressure-controlled face mask ventilation previously proved to be the least regimen to cause gastric insufflation in comparison to manual, and volume-controlled mask ventilation during induction of anesthesia. Later, a pressure of 15 cmH2O during face mask ventilation had been reported optimum to achieve the balance between adequate ventilation and reduced gastric insufflation in non-paralyzed patients. This finding was not yet replicated in paralyzed patients who represent the majority of population who receive mask ventilation during induction of anesthesia. We hypothesize that in paralyzed patient, the optimum pressure during face mask ventilation might be lower than the pressure which was previously reported in non-paralyzed patients. However, no studies to the best of our knowledge had confirmed this hypothesis.
Gastric insufflation was previously evaluated using auscultation with stethoscope, microphone placed in the epigastric area, or esophageal manometry. Recently, gastric antrum ultrasound was used successfully to gastric insufflation in real time by measuring the cross sectional area of gastric antrum before and after face mask ventilation. This newly developed method is more sensitive than the auscultatory method and less invasive than esophageal manometry method.
연구 개요
상태
상세 설명
Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 3-5 mg) will be administrated. End-tidal CO2 monitoring will be initiated after induction of general anesthesia and starting face-mask ventilation. Induction of anesthesia will be achieved using fentanyl (2 mcg/Kg), propofol (2 mg/Kg), and rocuronium (0.6 mg/Kg). After loss of verbal response, mask ventilation will be achieved by appropriate size face mask and oropharyngeal airway with 100% oxygen and double hand jaw thrust head tilt maneuver. The included patients will be randomly allocated to receive the assigned pressure-controlled mask ventilation. The 3 study groups will receive the planned inspiratory pressure, without positive end-expiratory pressure, with a respiratory rate of 15, and inspiratory to expiratory ratio of 1:2 for 180 seconds.
Assessment gastric insufflation during mask ventilation will be achieved by ultrasound assessment of gastric antrum (in the sagittal plane between left lobe of the liver and pancreas at level of the aorta) and auscultation by two blinded investigators to the assigned pressure. The ultrasound screen will be positioned to be not visible to the investigator responsible for auscultation. Gastric insufflation will be identified by comet-tail sign by gastric ultrasound and gurgling sound by auscultation.
Gastric antrum cross sectional area [ D1(longitudinal diameter) X D2 (anteroposterior diameter) X π /4] in between contractions in supine position before face mask ventilation and after insertion of endotracheal tube will be recorded. gastric insufflation will be identified if gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline.
During mask ventilation, the following parameter will be recorded at 30, 60, 90,120, 150 and 180 seconds; peripheral oxygen saturation, the end-tidal carbon dioxide concentration , peak airway measured pressure, and tidal volume Demographic data (age, sex, weight, height, BMI, comorbidities) will be recorded.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: ahmed hasanin, M.D
- 전화번호: +2 01095076954
- 이메일: ahmedmohamedhasanin@gmail.com
연구 장소
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Cairo, 이집트, 11562
- 모병
- Kasr Alaini Hospital
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연락하다:
- Anesthesia, Pain Management and Surgical ICU Department
- 전화번호: 00201222224057
- 이메일: Anesthesia.kasralainy@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- adult patients (above 18 years)
- American society of anesthesiologist I-II
- scheduled for elective non-cardiac surgery under general anesthesia
Exclusion Criteria:
- increased risk of difficult mask ventilation
- patients at risk of aspiration
- Patients with craniofacial anomalies
- BMI >35 kg/m2
- pregnant patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: pressure 10
mask ventilation with peak inspiratory pressure of 10 cmH2O
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pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O
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활성 비교기: pressure 15
mask ventilation with peak inspiratory pressure of 15 cmH2O
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pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O
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활성 비교기: pressure 20
mask ventilation with peak inspiratory pressure of 20 cmH2O
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pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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incidence of gastric insufflation by ultrasonography
기간: within 1 minute after endotracheal intubation
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gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline
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within 1 minute after endotracheal intubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gastric antrum cross sectional area
기간: 1 minute before mask ventilation and within 1 minute after endotracheal intubation
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gastric antrum longitudinal diameter X anteroposterior diameter X π /4 in between contractions in supine position
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1 minute before mask ventilation and within 1 minute after endotracheal intubation
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tidal volume
기간: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
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mL
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at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
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endtidal CO2
기간: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
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mmHg
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at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
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peripheral O2 saturation
기간: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
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percentage
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at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
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incidence of gastric insufflation by auscultation
기간: 1 minute after onset of mask ventilation
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gurgling sound by stethoscope
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1 minute after onset of mask ventilation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
peak inspiratory pressure 10 cmH2O에 대한 임상 시험
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National Cancer Institute (NCI)Eastern Cooperative Oncology Group; Cancer and Leukemia Group B; North Central Cancer Treatment...모집하지 않고 적극적으로유방 선암종미국, 페루, 남아프리카