Bronchial AspirationNCT05284084
Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay
A study testing Bed Head elevation, H2 blockers and mouth wash and Data collection for comparison in people with Bronchial Aspiration, run by Marshall University at 1 site in United States.
Trial summary
Patients of age >18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups: 1. Patients admitted to the ICU in the first 3-4 months will have their bed head elevated to 15 degrees + H2 blockers administration + mouth wash BID 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Aspiration
- What is being tested?
- Bed Head elevation, H2 blockers and mouth wash and Data collection for comparison
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 2 Nov 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
- Age>18
- All the patients admitted to ICU by surgery department.
- Development of aspiration pneumonia in patients admitted to ICU department of VA hospital.
- Aspiration Pneumonia development during hospital stay and treating physician indicated the diagnosis of aspiration pneumonia in history and physical exam notes.
Who cannot join
- Age <18
- Patient transferred or admitted to the hospital as a primary diagnosis of aspiration pneumonia (development of aspiration pneumonia prior to admission).
- Treating physician not documented aspiration pneumonia in history or physical exam notes.
- Drug overdose, seizure or cardiopulmonary arrest prior to hospital admission.
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshall University School of Medicine
Huntington, West Virginia, 25701
About this study
Patients of age >18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups:
- Patients admitted to the ICU in the first 3-4 months will have their bed head elevated to 15 degrees + H2 blockers administration + mouth wash BID
- Patients admitted to the ICU in the following 3-4 months will have their bed head elevated to 30 degrees + H2 blockers administration + mouth wash BID
- Patients admitted in the last 3-4 months will have their bed head elevated to 45 degrees + H2 blockers administration + mouth wash BID.
Read more
All patients will have their vital signs, BMI, and fluids ins and outs measured every 24 hours until the discharge from the ICU or death. All patients will be evaluated for GI functions (no vomiting, flatus+, bowel movement +, bowel sounds+, and KUB with normal gas distribution pattern) prior to oral intake.
Patients in the three groups will be matched by age, sex, and BMI with historical controls with broncho- aspiration (BA) (positive controls) and without BA events (negative controls) from a pool of 20,032 ICU admissions (01JAN2010 to 31DEC2019).
- Conditions
- Bronchial Aspiration
- Being tested
- Bed Head elevation, H2 blockers and mouth wash, Data collection for comparison
- Keywords
- Bronchial, Aspiration, Bronchoaspiration, Broncho-aspiration, ICU, Intensive Care Unit, Surgical patients, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed Head elevation, H2 blockers and mouth washOther
Elevation of the bed head to 15, 30 and 45 degrees, daily H2 blockers administration and mouth wash BID.
Data collection for comparisonOther
Data collection for comparison
| Study group | Role | What they receive |
|---|---|---|
| Negative Control | Placebo comparator | Matched subjects by age, sex and BMI with no BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019). Receives: Other: Data collection for comparison |
| Positive Control | Active comparator | Matched subjects by age, sex and BMI with BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019). Receives: Other: Data collection for comparison |
| Experimental group | Experimental | Consecutive subjects admitted to the ICU (these subjects will be matched with historical controls with and without BA events) from 30MAR2021 to 30MAR2022 on three subgroups:
* Head up from the bed 15 degrees + H2 blockers + mouth wash BID
* Head up from the bed 30 degrees + H2 blockers + mouth wash BID
* Head up from the bed 45 degrees + H2 blockers + mouth wash BID Receives: Other: Bed Head elevation, H2 blockers and mouth wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Bronchospiration pneumonia among study participants during their ICU admission
Calculating the number of subjects who developed bronchoaspiration pneumonia compared to the total number of ICU admission
Measured: 12 Months
Secondary outcomes (1)
Determine if there is an association between BA events and death rate in the ICU for the specified time period
Determining the factors impacting the rate of bronchaspiration and the rate of related death
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start3 Aug 2021
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Sanabria, Marshall University
- Investigators
- Juan Sanabria, MD MSc FACS, Principal investigator, Marshall University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284084
- Sponsor's protocol ID
- 945673-7
- Status last verified
- Apr 2023
- First submitted
- 18 Aug 2021
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Broncho-aspiration (BA) in Adult Subjects During Their ICU Stay
- ClinicalTrials.gov ID
- NCT05284084
- Acronym / sponsor ID
- 945673-7
- Conditions
- Bronchial Aspiration
- Keywords
- Bronchial, Aspiration, Bronchoaspiration, Broncho-aspiration, ICU, Intensive Care Unit, Surgical patients, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 17 Mar 2022 (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.
Patients of age >18 yo, admitted to the ICU through the surgery department from 2AUG2021 to 1AUG2022 will be divided into three groups:
- Patients admitted to the ICU in the first 3-4 months will have their bed head elevated to 15 degrees + H2 blockers administration + mouth wash BID
- Patients admitted to the ICU in the following 3-4 months will have their bed head elevated to 30 degrees + H2 blockers administration + mouth wash BID
- Patients admitted in the last 3-4 months will have their bed head elevated to 45 degrees + H2 blockers administration + mouth wash BID.
All patients will have their vital signs, BMI, and fluids ins and outs measured every 24 hours until the discharge from the ICU or death. All patients will be evaluated for GI functions (no vomiting, flatus+, bowel movement +, bowel sounds+, and KUB with normal gas distribution pattern) prior to oral intake.
Patients in the three groups will be matched by age, sex, and BMI with historical controls with broncho- aspiration (BA) (positive controls) and without BA events (negative controls) from a pool of 20,032 ICU admissions (01JAN2010 to 31DEC2019).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative Control | Placebo comparator | Other: Data collection for comparisonMatched subjects by age, sex and BMI with no BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019). |
| Positive Control | Active comparator | Other: Data collection for comparisonMatched subjects by age, sex and BMI with BA events, from a pool of 20,032 admission (01JAN2010 to 31DEC2019). |
| Experimental group | Experimental | Other: Bed Head elevation, H2 blockers and mouth washConsecutive subjects admitted to the ICU (these subjects will be matched with historical controls with and without BA events) from 30MAR2021 to 30MAR2022 on three subgroups: * Head up from the bed 15 degrees + H2 blockers + mouth wash BID * Head up from the bed 30 degrees + H2 blockers + mouth wash BID * Head up from the bed 45 degrees + H2 blockers + mouth wash BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18
- All the patients admitted to ICU by surgery department.
- Development of aspiration pneumonia in patients admitted to ICU department of VA hospital.
- Aspiration Pneumonia development during hospital stay and treating physician indicated the diagnosis of aspiration pneumonia in history and physical exam notes.
Key exclusion criteria (4 listed)
- Age <18
- Patient transferred or admitted to the hospital as a primary diagnosis of aspiration pneumonia (development of aspiration pneumonia prior to admission).
- Treating physician not documented aspiration pneumonia in history or physical exam notes.
- Drug overdose, seizure or cardiopulmonary arrest prior to hospital admission.
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 |
|---|---|---|
| Bed Head elevation, H2 blockers and mouth washElevation of the bed head to 15, 30 and 45 degrees, daily H2 blockers administration and mouth wash BID. | Other | Experimental group |
| Data collection for comparisonData collection for comparison | Other | Negative Control, Positive Control |
Primary outcome
Rate of Bronchospiration pneumonia among study participants during their ICU admission
Time frame: 12 Months
Calculating the number of subjects who developed bronchoaspiration pneumonia compared to the total number of ICU admission
1 secondary outcome
Determine if there is an association between BA events and death rate in the ICU for the specified time period
Time frame: 12 Months
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 4 Apr 2023.
- 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.
Juan Sanabria, MD MSc FACS principal investigator
Marshall University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed Head elevation, H2 blockers and mouth wash and Data collection for comparison in people with Bronchial Aspiration, run by Marshall University at 1 site in United States.
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 4 inclusion and 4 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 4 Apr 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Rate of Bronchospiration pneumonia among study participants during their ICU admission (time frame: 12 Months). 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 4 Apr 2023.