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.
A tanulmány áttekintése
Állapot
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: ahmed hasanin, M.D
- Telefonszám: +2 01095076954
- E-mail: ahmedmohamedhasanin@gmail.com
Tanulmányi helyek
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Cairo, Egyiptom, 11562
- Toborzás
- Kasr Alaini hospital
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Kapcsolatba lépni:
- Anesthesia, Pain Management and Surgical ICU Department
- Telefonszám: 00201222224057
- E-mail: Anesthesia.kasralainy@gmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: 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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Aktív összehasonlító: 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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Aktív összehasonlító: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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incidence of gastric insufflation by ultrasonography
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Gastric antrum cross sectional area
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- MD-250-2019
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