Pneumonia, AspirationNCT05728242
Point-of-care Gastric Ultrasound for Fracture Surgery
An observational study of Pneumonia, Aspiration and Gastric Content, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pneumonia, Aspiration, Gastric Content, Fractures, Bone
- What is being tested?
- Gastric ultrasound
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 Jul 2025
- How long will I take part?
- 2 Days
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been admitted to fracture surgery within 3 days of the trauma
Who may be able to join
- • American Society of Anesthesiologists (ASA) Physical Status classification I to III
- Patients necessitating surgery after traumatic fracture
Who cannot join
- • Patients with a body mass index over 35
- Diseases that may lead to gastroparesis (
- Known gastroesophageal reflux disease
- Known autonomic neuropathy
- Known diabetes mellitus
- Known or operated esophageal abnormalities
Show all 13Show fewer
- History of gastric surgery
- Acute gastric or peptic ulcus
- Pregnancy
- Preoperative narcotic analgesic usage
- Known connective tissue disorders like scleroderma or amyloidosis
- Known hiatal hernia
- Known gallbladder and choledochal stone
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haseki Training and Research Hospital
Istanbul
Berna Caliskan, MD, +905067108770, caliskan.b@gmail.com
About this study
Official title: Perioperative Point-of-care Gastric Ultrasound for Surgical Fracture Repair: Effect of Stress on Gastric Emptying
Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Since ultrasound has been a part of perioperative anesthesiology practice, it is simple to assess gastric content preoperatively with bedside ultrasonography (USG). More research is necessary to define elective surgeries with a possible risk of aspiration. Therefore, we aimed to evaluate the adequacy of standard fasting protocols in post-traumatic fracture surgery by measuring and evaluating gastric volume and content with USG in the preoperative operating room.
Read the detailed description
Pulmonary aspiration of the gastric content is an avoidable complication that can lead to severe morbidity and even mortality. Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Patients with gastrointestinal disorders or diabetes and conditions like pregnancy and obesity have been assessed because of possible delayed gastric emptying. Besides children, elderly and acute traumatic events have also been evaluated since they may not obey or fulfill preoperative fasting rules. Since ultrasound has been a part of perioperative anesthesiology practice, it is simple to assess gastric content preoperatively with bedside ultrasonography (USG). It may be logical to standardize gastric USG principally in situations concluding in decreased gastric peristalsis and gastric emptying. More research is necessary to define elective surgeries with possible risks.
Although recent studies have investigated the effect of gastric USG on risk stratification and clinical decision-making, especially in patients with special conditions, an investigation on patients scheduled for fracture surgery has not been evaluated. It is known that there is an inflammation process that extends up to the 4th day of trauma and an increase in stress hormones in fractures. Therefore, we aimed to evaluate the adequacy of standard fasting protocols in post-traumatic fracture surgery by evaluating gastric volume and content with USG in the preoperative operating room.
Material and Method Study design and study subjects The study was designed as prospective observational research after approval of our Institutional ethics committee (dossier no:142-2021) and planned to allocate at least 50 patients after obtaining written informed consent. Patients over 18 with the American Society of Anesthesiology (ASA) I-III who are scheduled for orthopedic surgery within three days after fracture are eligible for this study. Exclusion criteria are conditions or diseases affecting gastric emptying and peristalsis: body mass index over 35; gastroesophageal reflux disease; diabetes mellitus; esophageal abnormalities; history of gastric surgery; gastric or peptic ulcus; pregnancy; preoperative narcotic analgesic usage; connective tissue disorders like scleroderma or amyloidosis; hiatal hernia; gallbladder and choledochal stone.
Anesthesia, intervention, and post-interventional follow-up Patients are questioned about their fasting status; content and timing of the last food or drink. The attending anesthesiologist notes the decided anesthesia plan before intervention. An ultrasound examination is performed by another anesthesiologist, experienced with ultrasound at least for 5 years and all evaluations will be done by the same anesthesiologist. Gastric volume is investigated first in the supine and the right lateral decubitus position (RLD). Both qualitative (nature of gastric content) and quantitative (volume of gastric fluid) measurements are used to conclude the amount of gastric content and aspiration risk. For assessment 3 grade system will be used as described by Perlas. Grade 0, no gastric content within the antrum at both positions; Grade 1, gastric content is seen only at the RLD position; Grade 2 gastric content was detected in both positions. If gastric content is detected then, quantitive assessment is established by measuring antral area (Antral cross-sectional area = anterior-posterior diameter (D1) × craniocaudal diameter (D2) × π/4) and total gastric volume will be calculated with the formula (gastric volume (mL) = 27.0 + 14.6 x right-lat CSA - 1.28 x age). If the total gastric volume is over 1,5 ml /kg, grade 2; if 1,5- 0,8 ml/kg, grade 1; ˂ 0,8 ml/kg will be noted as grade 0. Finally, if the patient is considered to be grade 2, it will be evaluated as high aspiration risk, and if the anesthesia plan needs to be changed, it will be recorded as well. For patients concluded to have grades 1 and 2, postoperative follow-up will search for nausea and vomiting, fever, cough, tachypnea, and tachycardia within 48 hours. If any of these have occurred, aspiration pneumonia will be searched with further examination or imagination.
- Conditions
- Pneumonia, Aspiration, Gastric Content, Fractures, Bone
- Being tested
- Gastric ultrasound
- Keywords
- gastric ultrasound, aspiration pneumonia, gastric emptying, fracture surgery
- Medical subject headings
- Pneumonia, Aspiration, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDiagnostic test
Preoperative gastric antrum examination to detect gastric content (empty, liquid, or solid) and measure gastric volume
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric volume(ml)
gastric volume calculated with gastric volume (mL) = 27.0 + 14.6 x right-lat CSA - 1.28 x age and Antral cross-sectional area = anterior posterior diameter (D1) × cranio-caudal diameter (D2) × π/4 . Evaluation is done as over 1,5 ml /kg grade 2; if 1,5- 0,8 ml/kg, grade 1; ˂ 0,8 ml/kg, grade 0
Measured: preoperative, only one measurement
gastric content
Grade 0, no gastric content within the antrum at both positions ( supine and right lateral decubitis(RLD)); Grade 1, gastric content is seen only at RLD position; Grade 2 gastric content was detected in both positions
Measured: preoperative, only one examination
Secondary outcomes (2)
nausea or vomiting
postoperative nausea or vomiting
Measured: postoperative 24 hour
aspiration pneumonia
fever, cough, tachypnea, tachycardia within and if there is any of these has occured, aspiration pneumonia will be searched with further examination or imagination for certain diagnosis
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2023
- Primary completion15 Jul 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, AspirationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Caliskan, MD, Principal investigator, Haseki Training and Research Hospital Anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728242
- Sponsor's protocol ID
- 142-2021
- Status last verified
- Jun 2024
- First submitted
- 4 Feb 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alakkad H, Kruisselbrink R, Chin KJ, Niazi AU, Abbas S, Chan VW, Perlas A. Point-of-care ultrasound defines gastric content and changes the anesthetic management of elective surgical patients who have not followed fasting instructions: a prospective case series. Can J Anaesth. 2015 Nov;62(11):1188-95. doi: 10.1007/s12630-015-0449-1. Epub 2015 Aug 4.
PubMed 26239668Zhang G, Huang X, Shui Y, Luo C, Zhang L. Ultrasound to guide the individual medical decision by evaluating the gastric contents and risk of aspiration: A literature review. Asian J Surg. 2020 Dec;43(12):1142-1148. doi: 10.1016/j.asjsur.2020.02.008. Epub 2020 Mar 11.
PubMed 32171605
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Point-of-care Gastric Ultrasound for Surgical Fracture Repair: Effect of Stress on Gastric Emptying
- ClinicalTrials.gov ID
- NCT05728242
- Acronym / sponsor ID
- 142-2021
- Conditions
- Pneumonia, Aspiration, Gastric Content, Fractures, Bone
- Keywords
- gastric ultrasound, aspiration pneumonia, gastric emptying, fracture surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 15 Feb 2023 (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.
Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Since ultrasound has been a part of perioperative anesthesiology practice, it is simple to assess gastric content preoperatively with bedside ultrasonography (USG). More research is necessary to define elective surgeries with a possible risk of aspiration. Therefore, we aimed to evaluate the adequacy of standard fasting protocols in post-traumatic fracture surgery by measuring and evaluating gastric volume and content with USG in the preoperative operating room.
Detailed description
Pulmonary aspiration of the gastric content is an avoidable complication that can lead to severe morbidity and even mortality. Although there are fasting guidelines offered by the American Society of Anesthesiology (ASA) for managing preoperative patient assessment, some patients may need to be more cautious about the risk of aspiration. Patients with gastrointestinal disorders or diabetes and conditions like pregnancy and obesity have been assessed because of possible delayed gastric emptying. Besides children, elderly and acute traumatic events have also been evaluated since they may not obey or fulfill preoperative fasting rules. Since ultrasound has been a part of perioperative anesthesiology practice, it is simple to assess gastric content preoperatively with bedside ultrasonography (USG). It may be logical to standardize gastric USG principally in situations concluding in decreased gastric peristalsis and gastric emptying. More research is necessary to define elective surgeries with possible risks.
Although recent studies have investigated the effect of gastric USG on risk stratification and clinical decision-making, especially in patients with special conditions, an investigation on patients scheduled for fracture surgery has not been evaluated. It is known that there is an inflammation process that extends up to the 4th day of trauma and an increase in stress hormones in fractures. Therefore, we aimed to evaluate the adequacy of standard fasting protocols in post-traumatic fracture surgery by evaluating gastric volume and content with USG in the preoperative operating room.
Material and Method Study design and study subjects The study was designed as prospective observational research after approval of our Institutional ethics committee (dossier no:142-2021) and planned to allocate at least 50 patients after obtaining written informed consent. Patients over 18 with the American Society of Anesthesiology (ASA) I-III who are scheduled for orthopedic surgery within three days after fracture are eligible for this study. Exclusion criteria are conditions or diseases affecting gastric emptying and peristalsis: body mass index over 35; gastroesophageal reflux disease; diabetes mellitus; esophageal abnormalities; history of gastric surgery; gastric or peptic ulcus; pregnancy; preoperative narcotic analgesic usage; connective tissue disorders like scleroderma or amyloidosis; hiatal hernia; gallbladder and choledochal stone.
Anesthesia, intervention, and post-interventional follow-up Patients are questioned about their fasting status; content and timing of the last food or drink. The attending anesthesiologist notes the decided anesthesia plan before intervention. An ultrasound examination is performed by another anesthesiologist, experienced with ultrasound at least for 5 years and all evaluations will be done by the same anesthesiologist. Gastric volume is investigated first in the supine and the right lateral decubitus position (RLD). Both qualitative (nature of gastric content) and quantitative (volume of gastric fluid) measurements are used to conclude the amount of gastric content and aspiration risk. For assessment 3 grade system will be used as described by Perlas. Grade 0, no gastric content within the antrum at both positions; Grade 1, gastric content is seen only at the RLD position; Grade 2 gastric content was detected in both positions. If gastric content is detected then, quantitive assessment is established by measuring antral area (Antral cross-sectional area = anterior-posterior diameter (D1) × craniocaudal diameter (D2) × π/4) and total gastric volume will be calculated with the formula (gastric volume (mL) = 27.0 + 14.6 x right-lat CSA - 1.28 x age). If the total gastric volume is over 1,5 ml /kg, grade 2; if 1,5- 0,8 ml/kg, grade 1; ˂ 0,8 ml/kg will be noted as grade 0. Finally, if the patient is considered to be grade 2, it will be evaluated as high aspiration risk, and if the anesthesia plan needs to be changed, it will be recorded as well. For patients concluded to have grades 1 and 2, postoperative follow-up will search for nausea and vomiting, fever, cough, tachypnea, and tachycardia within 48 hours. If any of these have occurred, aspiration pneumonia will be searched with further examination or imagination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been admitted to fracture surgery within 3 days of the trauma
Key inclusion criteria (2 listed)
- • American Society of Anesthesiologists (ASA) Physical Status classification I to III
Key exclusion criteria (13 listed)
- • Patients with a body mass index over 35
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 ultrasoundPreoperative gastric antrum examination to detect gastric content (empty, liquid, or solid) and measure gastric volume | Diagnostic test | – |
Primary outcome
gastric volume(ml)
Time frame: preoperative, only one measurement
gastric volume calculated with gastric volume (mL) = 27.0 + 14.6 x right-lat CSA - 1.28 x age and Antral cross-sectional area = anterior posterior diameter (D1) × cranio-caudal diameter (D2) × π/4 . Evaluation is done as over 1,5 ml /kg grade 2; if 1,5- 0,8 ml/kg, grade 1; ˂ 0,8 ml/kg, grade 0
gastric content
Time frame: preoperative, only one examination
Grade 0, no gastric content within the antrum at both positions ( supine and right lateral decubitis(RLD)); Grade 1, gastric content is seen only at RLD position; Grade 2 gastric content was detected in both positions
2 secondary outcomes
nausea or vomiting
Time frame: postoperative 24 hour
aspiration pneumonia
Time frame: postoperative 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Results publication: PubMed 26239668Alakkad H, Kruisselbrink R, Chin KJ, Niazi AU, Abbas S, Chan VW, Perlas A. Point-of-care ultrasound defines gastric content and changes the anesthetic management of elective surgical patients who have not followed fasting instructions: a prospective case series. Can J Anaesth. 2015 Nov;62(11):1188-95. doi: 10.1007/s12630-015-0449-1. Epub 2015 Aug 4.
- Results publication: PubMed 32171605Zhang G, Huang X, Shui Y, Luo C, Zhang L. Ultrasound to guide the individual medical decision by evaluating the gastric contents and risk of aspiration: A literature review. Asian J Surg. 2020 Dec;43(12):1142-1148. doi: 10.1016/j.asjsur.2020.02.008. Epub 2020 Mar 11.
- Individual participant dataSharing planned: No
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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.
Berna Caliskan, MD principal investigator
Haseki Training and Research Hospital Anesthesiology and Reanimation Department
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 Pneumonia, Aspiration and Gastric Content, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 13 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 20 Mar 2025. 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 Turkey (Türkiye). 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 Berna Caliskan, MD (+905067108770, caliskan.b@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric volume(ml) (time frame: preoperative, only one measurement). The study lists 2 primary outcomes in all. 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 NCT05728242, which also lists 2 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 20 Mar 2025.