Aspiration PneumoniaNCT04544371
Ultrasound Assessment of Gastric Residual Volume in Obese Patients
An observational study of Aspiration Pneumonia, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Gastric emptying is a major risk factor for aspiration of gastric contents.Aspiration into the lungs represents a fatal complication that can occur during anesthesia. Not only gastric emptying importance to anesthetists is related to aspiration but also it is important to determine the systemic availability of… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- gastric ultrasound and nasogastric tube insertion
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2019to 30 Dec 2020
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This prospective observational study will be performed on 100 patients undergoing elective surgery in fayoum university
Who may be able to join
- Adult patients aged from 20 years to 60 years
- Patients scheduled for elective surgery after an 8-hour overnight fast after a light meal (200 ml milk, 50 g white cheese, and 120 g bread).
- American society of anesthesiologists physical status I-III.
Who cannot join
- Pregnancy
- Renal failure
- Liver cell failure
- History of upper GIT morbidity (hiatus hernia and gastric cancer)
- History of upper abdominal surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate Egypt, 63514
About this study
Official title: Evaluation of Gastric Residual Volume in Fasting Obese Patients Using Gastric Ultrasound: a Comparative Study
Gastric emptying is a major risk factor for aspiration of gastric contents.Aspiration into the lungs represents a fatal complication that can occur during anesthesia.
Not only gastric emptying importance to anesthetists is related to aspiration but also it is important to determine the systemic availability of substances given through the mouth. Delayed gastric emptying represents a major danger as it causes nausea and vomiting and prevents a return to oral feeding. Lastly it may cause morbidity and mortality.
Read more
Both humoral and neural influences have their impact on emptying. Volume and composition of gastric food act as major determinants for the rate of gastric emptying. The effect of body weight on gastric emptying are inconsistent.
ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia.
These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying.
Ultrasound can be used perioperatively to asses gastric content and volume at bedside.
Read the detailed description
The objective of the current study is to evaluate gastric residual volume in obese patients versus healthy controls scheduled for elective surgery, using gastric ultrasound.
This prospective observational study was performed on 100 patients undergoing elective surgery from July 2019 to June 2020 at Fayoum University hospital after approval of the local institutional ethical committee (M420). A detailed informed consent was signed by the eligible participants before enrollment.
Our study adheres to the CONSORT guidelines. The study was conducted on 100 Patients were assigned to one of two groups of (50) patients in each group. Group obese ASA II from( 30-40) BMI, ASA III above 40 BMI without other comorbidities and group non obese ASA I control.Obese patients whose BMI >30 and healthy patients whose BMI = 18-24.9 who was scheduled for an elective surgery were included in this trial. All patients were enrolled in the study aged above >20 y. This study included patients scheduled for elective surgery after 8-hour overnight fast after a light meal.
Ultrasound scanning:
Focused gastric ultrasound by was performed by a trained physician in semi-sitting position then right lateral position using low frequency (2-5MHz) mindray curved transducer and mindray DP-20 ultrasound system. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark.
The antrum was considered to be empty if flat with juxtaposed anterior and posterior walls, fluid-containing if distended with thin walls and hypoechoic contents, solid -containing if distended with a content with mixed echogenicity according to antral shape and contents .
The antral cross sectional area (CSA) was measured using the two antral dimensions, craniocaudal (D1) and anteroposterior (D2) dimensions, according to the following equation: π [D1×D2]/4 provided that π = 22/7.
The gastric residual volume was calculated according to patient position as follows:
Bouvet and colleagues equation for semi-sitting position: gastric residual volume (ml) =215 + 57 log CSA (mm2) - 0.78 age (year) - 0.16 height (cm) - 0.25 weight (kg) - 0.80 ASA.
Perlas and colleagues equation for right lateral position: gastric residual volume (ml) = 27.0 + 14.6 × right-lateral CSA - 1.28 × age.
Using the classification of Ven de Putte and perlas, the study could asses the risk of aspiration as follows: (a) low risk of aspiration: patients with empty antrum and patients with gastric residual volume less than 1.5 ml/kg.(b) high risk of aspiration: patients with solid contents and patients with gastric residual volume more than 1.5 ml/kg.
Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.
Statistical Analysis The collected data were organized, tabulated and statistically analyzed using SPSS software statistical computer package version 22 (SPSS Inc, USA). Numerical variables were not normally distributed and were presented as median and interquartile range (IQR); Mann-Whitney U test was used as a test of significant. Qualitative data were presented as numbers and percentages, and the chi-squared test was used to determine significance. A two-sided P-value of <0.05 was considered statistically significant.
Sample size Sample size calculated using G-Power© software version 3.1.7 results with effect size (0.57), two sided (two tails) type I error 0.05 and power of 80%, each group should include at least (50) Subjects. the authors expected no dropout rates or missing data.
- Conditions
- Aspiration Pneumonia
- Being tested
- gastric ultrasound, nasogastric tube insertion
- Keywords
- Gastric residual volume, Obese, Ultrasound, Aspiration
- Medical subject headings
- Pneumonia, Aspiration, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric ultrasoundDevice
Focused gastric ultrasound was performed in semi-sitting position then right lateral position mindray curved transducer for examination of abdomen with low frequency (2-5 MHz) by a trained physician. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark
nasogastric tube insertionProcedure or surgery
Also called Ryle tube
Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.
| Study group | Role | What they receive |
|---|---|---|
| normal weight patients | patients with body mass index =18-24.9 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area in semi-sitting and right lateral positions Receives: Device: gastric ultrasound; Procedure: nasogastric tube insertion | |
| obese patients | patients with body mass index >30 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area semi-sitting and right lateral positions Receives: Device: gastric ultrasound; Procedure: nasogastric tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of gastric residual volume in semi-sitting position
in cubic centimetre
Measured: 5 minutes preoperatively
Secondary outcomes (6)
measurement of gastric residual volume in right lateral position.
in cubic centimetre
Measured: 5 minutes preoperatively
Antral cross sectional area in semi-sitting position
in millimetre square
Measured: 5 minutes preoperatively
Antral cross sectional area in right lateral position
in millimetre square
Measured: 5 minutes preoperatively
volume of fluid aspirated from nasogastric tube
in cubic centimetre
Measured: 1 minute after induction of anesthesia
grade of aspiration risk
less (low risk) or more (high risk) 1.5 millilitre/kilogram
Measured: 5 minutes preoperatively
Grading for assessment of antrum of the stomach
: 3 points as follows: grade 0: empty antrum, grade 1: minimal fluid in right lateral position only, grade 2: distention of antrum in both right lateral and semi-sitting position
Measured: 5 minutes preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start15 Oct 2019
- Primary completion20 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Mohamed Sayed mahmoud, Fayoum University Hospital
- Investigators
- Atef M sayed, MD, Principal investigator, Fayoum Universitymaged L Bolis, MD, Study chair, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544371
- Sponsor's protocol ID
- M420
- Status last verified
- Feb 2021
- First submitted
- 3 Sep 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun H, Wu CW, Zhang D, Makay O, Zhao Y, Carcofaro P, Kim HY, Dionigi G, Pino A, Caruso E, Pontin A, Pappalardo V. New Paradigms for Neural Monitoring in Thyroid Surgery. Surg Technol Int. 2019 May 15;34:79-86.
PubMed 30664223Bakalinis E, Makris I, Demesticha T, Tsakotos G, Skandalakis P, Filippou D. Non-Recurrent Laryngeal Nerve and Concurrent Vascular Variants: A Review. Acta Med Acad. 2018 Nov;47(2):186-192. doi: 10.5644/ama2006-124.230.
PubMed 30585070Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.
PubMed 16563326Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
PubMed 21364462Zaremba S, Shin CH, Hutter MM, Malviya SA, Grabitz SD, MacDonald T, Diaz-Gil D, Ramachandran SK, Hess D, Malhotra A, Eikermann M. Continuous Positive Airway Pressure Mitigates Opioid-induced Worsening of Sleep-disordered Breathing Early after Bariatric Surgery. Anesthesiology. 2016 Jul;125(1):92-104. doi: 10.1097/ALN.0000000000001160.
PubMed 27171827
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastric Residual Volume in Fasting Obese Patients Using Gastric Ultrasound: a Comparative Study
- ClinicalTrials.gov ID
- NCT04544371
- Acronym / sponsor ID
- M420
- Conditions
- Aspiration Pneumonia
- Keywords
- Gastric residual volume, Obese, Ultrasound, Aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 10 Sep 2020 (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.
Gastric emptying is a major risk factor for aspiration of gastric contents.Aspiration into the lungs represents a fatal complication that can occur during anesthesia.
Not only gastric emptying importance to anesthetists is related to aspiration but also it is important to determine the systemic availability of substances given through the mouth. Delayed gastric emptying represents a major danger as it causes nausea and vomiting and prevents a return to oral feeding. Lastly it may cause morbidity and mortality.
Both humoral and neural influences have their impact on emptying. Volume and composition of gastric food act as major determinants for the rate of gastric emptying. The effect of body weight on gastric emptying are inconsistent.
ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia.
These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying.
Ultrasound can be used perioperatively to asses gastric content and volume at bedside.
Detailed description
The objective of the current study is to evaluate gastric residual volume in obese patients versus healthy controls scheduled for elective surgery, using gastric ultrasound.
This prospective observational study was performed on 100 patients undergoing elective surgery from July 2019 to June 2020 at Fayoum University hospital after approval of the local institutional ethical committee (M420). A detailed informed consent was signed by the eligible participants before enrollment.
Our study adheres to the CONSORT guidelines. The study was conducted on 100 Patients were assigned to one of two groups of (50) patients in each group. Group obese ASA II from( 30-40) BMI, ASA III above 40 BMI without other comorbidities and group non obese ASA I control.Obese patients whose BMI >30 and healthy patients whose BMI = 18-24.9 who was scheduled for an elective surgery were included in this trial. All patients were enrolled in the study aged above >20 y. This study included patients scheduled for elective surgery after 8-hour overnight fast after a light meal.
Ultrasound scanning:
Focused gastric ultrasound by was performed by a trained physician in semi-sitting position then right lateral position using low frequency (2-5MHz) mindray curved transducer and mindray DP-20 ultrasound system. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark.
The antrum was considered to be empty if flat with juxtaposed anterior and posterior walls, fluid-containing if distended with thin walls and hypoechoic contents, solid -containing if distended with a content with mixed echogenicity according to antral shape and contents .
The antral cross sectional area (CSA) was measured using the two antral dimensions, craniocaudal (D1) and anteroposterior (D2) dimensions, according to the following equation: π [D1×D2]/4 provided that π = 22/7.
The gastric residual volume was calculated according to patient position as follows:
Bouvet and colleagues equation for semi-sitting position: gastric residual volume (ml) =215 + 57 log CSA (mm2) - 0.78 age (year) - 0.16 height (cm) - 0.25 weight (kg) - 0.80 ASA.
Perlas and colleagues equation for right lateral position: gastric residual volume (ml) = 27.0 + 14.6 × right-lateral CSA - 1.28 × age.
Using the classification of Ven de Putte and perlas, the study could asses the risk of aspiration as follows: (a) low risk of aspiration: patients with empty antrum and patients with gastric residual volume less than 1.5 ml/kg.(b) high risk of aspiration: patients with solid contents and patients with gastric residual volume more than 1.5 ml/kg.
Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.
Statistical Analysis The collected data were organized, tabulated and statistically analyzed using SPSS software statistical computer package version 22 (SPSS Inc, USA). Numerical variables were not normally distributed and were presented as median and interquartile range (IQR); Mann-Whitney U test was used as a test of significant. Qualitative data were presented as numbers and percentages, and the chi-squared test was used to determine significance. A two-sided P-value of <0.05 was considered statistically significant.
Sample size Sample size calculated using G-Power© software version 3.1.7 results with effect size (0.57), two sided (two tails) type I error 0.05 and power of 80%, each group should include at least (50) Subjects. the authors expected no dropout rates or missing data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal weight patients | – | Device: gastric ultrasound, Procedure: nasogastric tube insertionpatients with body mass index =18-24.9 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area in semi-sitting and right lateral positions |
| obese patients | – | Device: gastric ultrasound, Procedure: nasogastric tube insertionpatients with body mass index >30 kg/m2 will be examined by abdominal ultrasound to assess gastric antrum cross sectional area semi-sitting and right lateral positions |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective observational study will be performed on 100 patients undergoing elective surgery in fayoum university
Key inclusion criteria (3 listed)
- Adult patients aged from 20 years to 60 years
- Patients scheduled for elective surgery after an 8-hour overnight fast after a light meal (200 ml milk, 50 g white cheese, and 120 g bread).
- American society of anesthesiologists physical status I-III.
Key exclusion criteria (5 listed)
- Pregnancy
- Renal failure
- Liver cell failure
- History of upper GIT morbidity (hiatus hernia and gastric cancer)
- History of upper abdominal surgery.
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 |
|---|---|---|
| gastric ultrasoundFocused gastric ultrasound was performed in semi-sitting position then right lateral position mindray curved transducer for examination of abdomen with low frequency (2-5 MHz) by a trained physician. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark | Device | normal weight patients, obese patients |
| nasogastric tube insertionAlso: Ryle tubeNasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position. | Procedure or surgery | normal weight patients, obese patients |
Primary outcome
measurement of gastric residual volume in semi-sitting position
Time frame: 5 minutes preoperatively
in cubic centimetre
6 secondary outcomes
measurement of gastric residual volume in right lateral position.
Time frame: 5 minutes preoperatively
Antral cross sectional area in semi-sitting position
Time frame: 5 minutes preoperatively
Antral cross sectional area in right lateral position
Time frame: 5 minutes preoperatively
volume of fluid aspirated from nasogastric tube
Time frame: 1 minute after induction of anesthesia
grade of aspiration risk
Time frame: 5 minutes preoperatively
Grading for assessment of antrum of the stomach
Time frame: 5 minutes preoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 30664223Sun H, Wu CW, Zhang D, Makay O, Zhao Y, Carcofaro P, Kim HY, Dionigi G, Pino A, Caruso E, Pontin A, Pappalardo V. New Paradigms for Neural Monitoring in Thyroid Surgery. Surg Technol Int. 2019 May 15;34:79-86.
- Background: PubMed 30585070Bakalinis E, Makris I, Demesticha T, Tsakotos G, Skandalakis P, Filippou D. Non-Recurrent Laryngeal Nerve and Concurrent Vascular Variants: A Review. Acta Med Acad. 2018 Nov;47(2):186-192. doi: 10.5644/ama2006-124.230.
- Background: PubMed 16563326Neelakanta G, Chikyarappa A. A review of patients with pulmonary aspiration of gastric contents during anesthesia reported to the Departmental Quality Assurance Committee. J Clin Anesth. 2006 Mar;18(2):102-7. doi: 10.1016/j.jclinane.2005.07.002.
- Background: PubMed 21364462Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.
- Background: PubMed 27171827Zaremba S, Shin CH, Hutter MM, Malviya SA, Grabitz SD, MacDonald T, Diaz-Gil D, Ramachandran SK, Hess D, Malhotra A, Eikermann M. Continuous Positive Airway Pressure Mitigates Opioid-induced Worsening of Sleep-disordered Breathing Early after Bariatric Surgery. Anesthesiology. 2016 Jul;125(1):92-104. doi: 10.1097/ALN.0000000000001160.
- Individual participant dataSharing planned: Undecided
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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.
Atef M sayed, MD principal investigator
Fayoum University
maged L Bolis, MD study chair
Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration Pneumonia, run by Fayoum University 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: finished, as of the sponsor's last update on 2 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of gastric residual volume in semi-sitting position (time frame: 5 minutes preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04544371, which also lists 5 linked publications.
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 2 Feb 2021.