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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Egypt

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.

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 groups in NCT04544371
Study groupRoleWhat they receive
normal weight patientspatients 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 patientspatients 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.

  1. measurement of gastric residual volume in semi-sitting position

    in cubic centimetre

    Measured: 5 minutes preoperatively

Secondary outcomes (6)
  1. measurement of gastric residual volume in right lateral position.

    in cubic centimetre

    Measured: 5 minutes preoperatively

  2. Antral cross sectional area in semi-sitting position

    in millimetre square

    Measured: 5 minutes preoperatively

  3. Antral cross sectional area in right lateral position

    in millimetre square

    Measured: 5 minutes preoperatively

  4. volume of fluid aspirated from nasogastric tube

    in cubic centimetre

    Measured: 1 minute after induction of anesthesia

  5. grade of aspiration risk

    less (low risk) or more (high risk) 1.5 millilitre/kilogram

    Measured: 5 minutes preoperatively

  6. 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.

  1. First posted10 Sep 2020
  2. Study start15 Oct 2019
  3. Primary completion20 Dec 2020
  4. Study completion30 Dec 2020

Resources

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)
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 30664223
  • Bakalinis 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 30585070
  • Neelakanta 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 16563326
  • Bouvet 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 21364462
  • Zaremba 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

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.

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