Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation

NCT05020548 | Unknown

• 1 other identifier: MD-250-2019
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Ultrasonography; Gastric Insufflation; Mask Ventilation

Outcome Measures

Primary Outcomes (1)

• incidence of gastric insufflation by ultrasonography

  gastric antrum cross sectional area increased by \> 30% after endotracheal intubation in relation to the baseline

  within 1 minute after endotracheal intubation

Secondary Outcomes (5)

• Gastric antrum cross sectional area

  1 minute before mask ventilation and within 1 minute after endotracheal intubation

• tidal volume

  at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation

• endtidal CO2

  at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation

• peripheral O2 saturation

  at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation

• incidence of gastric insufflation by auscultation

  1 minute after onset of mask ventilation

Study Arms (3)

pressure 10

ACTIVE COMPARATOR

mask ventilation with peak inspiratory pressure of 10 cmH2O

Other: peak inspiratory pressure 10 cmH2O

pressure 15

ACTIVE COMPARATOR

mask ventilation with peak inspiratory pressure of 15 cmH2O

Other: peak inspiratory pressure 15 cmH2O

pressure 20

ACTIVE COMPARATOR

mask ventilation with peak inspiratory pressure of 20 cmH2O

Other: peak inspiratory pressure 20 cmH2O

Interventions

peak inspiratory pressure 10 cmH2O OTHER

pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O

pressure 10

peak inspiratory pressure 15 cmH2O OTHER

pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O

pressure 15

peak inspiratory pressure 20 cmH2O OTHER

pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O

pressure 20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (above 18 years)
• American society of anesthesiologist I-II
• scheduled for elective non-cardiac surgery under general anesthesia

You may not qualify if:

• increased risk of difficult mask ventilation
• patients at risk of aspiration
• Patients with craniofacial anomalies
• BMI \>35 kg/m2
• pregnant patients

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

RECRUITING

Central Study Contacts

ahmed hasanin, M.D

CONTACT

01095076954; ahmedmohamedhasanin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: September 9, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

EG (1)