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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05020548
Enrollment
111
Registered
2021-08-25
Start date
2021-09-09
Completion date
2021-12-31
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Insufflation, Gastric Ultrasonography, Mask Ventilation

Brief summary

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.

Detailed description

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.

Interventions

OTHERpeak inspiratory pressure 10 cmH2O

pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O

OTHERpeak inspiratory pressure 15 cmH2O

pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O

OTHERpeak inspiratory pressure 20 cmH2O

pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of gastric insufflation by ultrasonographywithin 1 minute after endotracheal intubationgastric antrum cross sectional area increased by \> 30% after endotracheal intubation in relation to the baseline

Secondary

MeasureTime frameDescription
Gastric antrum cross sectional area1 minute before mask ventilation and within 1 minute after endotracheal intubationgastric antrum longitudinal diameter X anteroposterior diameter X π /4 in between contractions in supine position
tidal volumeat 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilationmL
endtidal CO2at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilationmmHg
peripheral O2 saturationat 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilationpercentage
incidence of gastric insufflation by auscultation1 minute after onset of mask ventilationgurgling sound by stethoscope

Countries

Egypt

Contacts

Primary Contactahmed hasanin, M.D
ahmedmohamedhasanin@gmail.com01095076954

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026