AnesthesiaNCT04159636
Pulmonary Aspiration in Elderly Patients
A study testing Carbohydrate beverage in people with Anesthesia, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of this study was to compare the risk of pulmonary aspiration assessed with gastric ultrasonography in elderly patients, undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Carbohydrate beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2020to 6 Aug 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged from 65
- scheduled for elective surgery
- American Society of Anesthesiologists physical status 1 or 2
Who cannot join
- Diagnosed for diseases that might delay gastric emptying (obesity, diabetes, hiatal hernia, gastro-esophageal reflux disease, ileus)
- psychiatric or mental disorders
- delirium
- dementia
- parkinsonism
- alcoholism
- drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Risk of Pulmonary Aspiration Assessed by Gastric Ultrasound in Elderly Patients in Fasting Group vs. Carbohydrate Loading Group
The aim of this study was to compare the risk of pulmonary aspiration assessed with gastric ultrasonography in elderly patients, undergoing elective surgery.
Read the detailed description
Recently, carbohydrate loading is suggested for enhanced recovery after surgery.
Aging process often accompanies gastrointestinal dysmotility. Therefore, elderly patients might have undiagnosed gastro-esophageal reflux disease, or other gastrointestinal disorders. Moreover, because of their co-morbid underlying diseases and multi-drug effects, gastric emptying might be further delayed in the elderly patients.
This study was designated to compared the risk of pulmonary aspiration in elderly patients, with gastric ultrasound between fasting group and carbohydrate loading group.
- Conditions
- Anesthesia
- Being tested
- Carbohydrate beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate beverageOther
The participants in this group are allowed to drink carbohydrate until 2 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Fasting group | No intervention | Participants will be remained fasted until surgery |
| Carbohydrate group | Experimental | Participants will be allowed to drink carbohydrate beverage before 2 hours of surgery Receives: Other: Carbohydrate beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2
Incidence of Perlas grade 2. Clear fluid is detected in gastric antrum by gastric antral ultrasound on both supine and right lateral decubitus position.
Perlas grade 2: fluid appears in both supine and right lateral decubitus positions Perlas grade 1: fluid is detected only in right decubitus position Perlas grade 0: fluid is not detected in both supine and right lateral decubitus positions.
Measured: 2 hours after intake of last allowable carbohydrate drink time
Secondary outcomes (2)
cross-sectional area of gastric antrum in supine position
cross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4
Measured: 2 hours after intake of last allowable carbohydrate drink time
cross-sectional area of gastric antrum in right decubitus position
cross sectional area of gastric antrum is calculated by using the following formula: cross-sectional area = long axis x short axis x 3.14 /4
Measured: 2 hours after intake of last allowable carbohydrate drink time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start7 Jan 2020
- Primary completion6 Aug 2020
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159636
- Sponsor's protocol ID
- KBSMC 2019-10-013
- Status last verified
- Oct 2020
- First submitted
- 3 Nov 2019
- Last updated
- 29 Oct 2020
- 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 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Risk of Pulmonary Aspiration Assessed by Gastric Ultrasound in Elderly Patients in Fasting Group vs. Carbohydrate Loading Group
- ClinicalTrials.gov ID
- NCT04159636
- Acronym / sponsor ID
- KBSMC 2019-10-013
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 12 Nov 2019 (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.
The aim of this study was to compare the risk of pulmonary aspiration assessed with gastric ultrasonography in elderly patients, undergoing elective surgery.
Detailed description
Recently, carbohydrate loading is suggested for enhanced recovery after surgery.
Aging process often accompanies gastrointestinal dysmotility. Therefore, elderly patients might have undiagnosed gastro-esophageal reflux disease, or other gastrointestinal disorders. Moreover, because of their co-morbid underlying diseases and multi-drug effects, gastric emptying might be further delayed in the elderly patients.
This study was designated to compared the risk of pulmonary aspiration in elderly patients, with gastric ultrasound between fasting group and carbohydrate loading group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting group | No intervention | –Participants will be remained fasted until surgery |
| Carbohydrate group | Experimental | Other: Carbohydrate beverageParticipants will be allowed to drink carbohydrate beverage before 2 hours of surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- aged from 65
- scheduled for elective surgery
- American Society of Anesthesiologists physical status 1 or 2
Key exclusion criteria (7 listed)
- Diagnosed for diseases that might delay gastric emptying (obesity, diabetes, hiatal hernia, gastro-esophageal reflux disease, ileus)
- psychiatric or mental disorders
- delirium
- dementia
- parkinsonism
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 |
|---|---|---|
| Carbohydrate beverageThe participants in this group are allowed to drink carbohydrate until 2 hours before surgery | Other | Carbohydrate group |
Primary outcome
Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2
Time frame: 2 hours after intake of last allowable carbohydrate drink time
Incidence of Perlas grade 2. Clear fluid is detected in gastric antrum by gastric antral ultrasound on both supine and right lateral decubitus position. Perlas grade 2: fluid appears in both supine and right lateral decubitus positions Perlas grade 1: fluid is detected only in right decubitus position Perlas grade 0: fluid is not detected in both supine and right lateral decubitus positions.
2 secondary outcomes
cross-sectional area of gastric antrum in supine position
Time frame: 2 hours after intake of last allowable carbohydrate drink time
cross-sectional area of gastric antrum in right decubitus position
Time frame: 2 hours after intake of last allowable carbohydrate drink time
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 29 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate beverage in people with Anesthesia, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 7 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 29 Oct 2020. 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 South Korea. 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?
Incidence of risk of pulmonary aspiration assessed by gastric ultrasound defined by Perlas grade 2 (time frame: 2 hours after intake of last allowable carbohydrate drink time). 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 29 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.