Gastric UltrasonographyNCT05020548
Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation
A study testing peak inspiratory pressure 10 cmH2O, peak inspiratory pressure 15 cmH2O and peak inspiratory pressure 20 cmH2O in people with Gastric Ultrasonography and Gastric Insufflation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ultrasonography, Gastric Insufflation, Mask Ventilation
- What is being tested?
- peak inspiratory pressure 10 cmH2O, peak inspiratory pressure 15 cmH2O and peak inspiratory pressure 20 cmH2O
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (above 18 years)
- American society of anesthesiologist I-II
- scheduled for elective non-cardiac surgery under general anesthesia
Who cannot join
- increased risk of difficult mask ventilation
- patients at risk of aspiration
- Patients with craniofacial anomalies
- BMI >35 kg/m2
- pregnant patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alaini Hospital
Cairo, 11562
Anesthesia, Pain Management and Surgical ICU Department, 00201222224057, Anesthesia.kasralainy@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- peak inspiratory pressure 10 cmH2O, peak inspiratory pressure 15 cmH2O, peak inspiratory pressure 20 cmH2O
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peak inspiratory pressure 10 cmH2OOther
pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O
peak inspiratory pressure 15 cmH2OOther
pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O
peak inspiratory pressure 20 cmH2OOther
pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| pressure 10 | Active comparator | mask ventilation with peak inspiratory pressure of 10 cmH2O Receives: Other: peak inspiratory pressure 10 cmH2O |
| pressure 15 | Active comparator | mask ventilation with peak inspiratory pressure of 15 cmH2O Receives: Other: peak inspiratory pressure 15 cmH2O |
| pressure 20 | Active comparator | mask ventilation with peak inspiratory pressure of 20 cmH2O Receives: Other: peak inspiratory pressure 20 cmH2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gastric insufflation by ultrasonography
gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline
Measured: within 1 minute after endotracheal intubation
Secondary outcomes (5)
Gastric antrum cross sectional area
gastric antrum longitudinal diameter X anteroposterior diameter X π /4 in between contractions in supine position
Measured: 1 minute before mask ventilation and within 1 minute after endotracheal intubation
tidal volume
mL
Measured: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
endtidal CO2
mmHg
Measured: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
peripheral O2 saturation
percentage
Measured: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
incidence of gastric insufflation by auscultation
gurgling sound by stethoscope
Measured: 1 minute after onset of mask ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start9 Sep 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mostafa Ahmad, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020548
- Sponsor's protocol ID
- MD-250-2019
- Status last verified
- Sep 2021
- First submitted
- 19 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05020548
- Acronym / sponsor ID
- MD-250-2019
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pressure 10 | Active comparator | Other: peak inspiratory pressure 10 cmH2Omask ventilation with peak inspiratory pressure of 10 cmH2O |
| pressure 15 | Active comparator | Other: peak inspiratory pressure 15 cmH2Omask ventilation with peak inspiratory pressure of 15 cmH2O |
| pressure 20 | Active comparator | Other: peak inspiratory pressure 20 cmH2Omask ventilation with peak inspiratory pressure of 20 cmH2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients (above 18 years)
- American society of anesthesiologist I-II
- scheduled for elective non-cardiac surgery under general anesthesia
Key exclusion criteria (5 listed)
- increased risk of difficult mask ventilation
- patients at risk of aspiration
- Patients with craniofacial anomalies
- BMI >35 kg/m2
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peak inspiratory pressure 10 cmH2Opressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O | Other | pressure 10 |
| peak inspiratory pressure 15 cmH2Opressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O | Other | pressure 15 |
| peak inspiratory pressure 20 cmH2Opressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O | Other | pressure 20 |
Primary outcome
incidence of gastric insufflation by ultrasonography
Time frame: within 1 minute after endotracheal intubation
gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline
5 secondary outcomes
Gastric antrum cross sectional area
Time frame: 1 minute before mask ventilation and within 1 minute after endotracheal intubation
tidal volume
Time frame: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
endtidal CO2
Time frame: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
peripheral O2 saturation
Time frame: at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
incidence of gastric insufflation by auscultation
Time frame: 1 minute after onset of mask ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peak inspiratory pressure 10 cmH2O, peak inspiratory pressure 15 cmH2O and peak inspiratory pressure 20 cmH2O in people with Gastric Ultrasonography and Gastric Insufflation, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed hasanin, M.D (01095076954 ext. +2, ahmedmohamedhasanin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of gastric insufflation by ultrasonography (time frame: within 1 minute after endotracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.