Foreign Body; InhalationNCT04988113
Presentation And Management Of Neglected Inhaled Foreign Body At Sohag University Hospital
An observational study of Foreign Body; Inhalation, run by Sohag University at 1 site in Egypt.
Trial summary
Delayed presentation is not uncommon in children and may have been treated as asthma due to associated with low-grade cough and noisy breathing. Late diagnoses of foreign body aspiration were defined as occurring beyond 3 days after the aspiration of the foreign body, or onset of symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Foreign Body; Inhalation
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were diagnosed with neglected inhaled foreign body who underwent bronchoscopy in sohag university hospital
Who may be able to join
- Patients who were diagnosed with neglected inhaled foreign body who underwent bronchoscopy in sohag university hospital, all ages, both Gender.
Who cannot join
- Patients who were diagnosed with recent inhaled foreign body.
Trial locations and contacts
1 site in 1 country.
Mostafa A Mohamed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
usama R El-Sherif, professor
About this study
Delayed presentation is not uncommon in children and may have been treated as asthma due to associated with low-grade cough and noisy breathing.
Late diagnoses of foreign body aspiration were defined as occurring beyond 3 days after the aspiration of the foreign body, or onset of symptoms.
Undiagnosed foreign body aspiration can cause mechanical effects, chemical reactions, and the most common complications were pneumonia, asthma, lung collapse, bronchiectasis, emphysema, mediastinal shift, atelectasis and lung abscess. Long-term presence of FBs in the bronchus may lead to bronchial stenosis
Read the detailed description
A foreign body is an endogenous or exogenous substance, different from the anatomy of the site where it is found. Chevalier Jackson defined a foreign body as "an object or a substance that is foreign to its location".
Aspiration of a foreign body (FB) is a potentially life-threatening emergency and 75% of cases occur in children younger than 3 years of age, due to the absence of molar teeth, underdeveloped swallowing coordination and the tendency to talk and play while eating .
However, foreign body aspiration does happen in adults and elderly people as well.
Obtaining a good history plays a vital role in effectively diagnosing a foreign body aspiration. Three clinical phases of aspiration of foreign bodies are recognized: The first stage is the impaction of the foreign body and entitled "penetration syndrome," defined as a sudden onset of choking and intractable cough with or without vomiting.
In the second stage, these symptoms diminish as the foreign body settles into a stationary location and the tracheoesophageal reflexes tire out; this asymptomatic stage can last hours to weeks, which may delay diagnosis. In the third phase, Complications occur (also defined as Complications phase), when obstruction, erosion or infection cause pneumonia, atelectasis, abscess or fever. The first presentation of the condition may actually represent a complication of inhaled foreign body.
Delayed presentation is not uncommon in children and may have been treated as asthma due to associated with low-grade cough and noisy breathing.
Late diagnoses of foreign body aspiration were defined as occurring beyond 3 days after the aspiration of the foreign body, or onset of symptoms.
Undiagnosed foreign body aspiration can cause mechanical effects, chemical reactions, and the most common complications were pneumonia, asthma, lung collapse, bronchiectasis, emphysema, mediastinal shift, atelectasis and lung abscess. Long-term presence of FBs in the bronchus may lead to bronchial stenosis.
Neglected foreign bodies in the respiratory tract may occur due to misdiagnosis by the fellow professionals and pediatricians when FBs in the upper tracheal airway produce symptoms similar to those of viral subglottic croup or due to lack of typical symptoms and signs. The most common symptoms and signs of FBA, namely coughing, wheezing, and decreased air entry, can easily be overlooked by bronchial asthma or pneumonia. Parental negligence, not conclusive chest radiographs, and false negative bronchoscopic findings are other blamed factors
- Conditions
- Foreign Body; Inhalation
- Medical subject headings
- Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of different pictures of clinical presentations in neglected inhaled foreign body.
This is a retrospective study that will be conducted in our tertiary center "Sohag University Hospital", will include cases of neglected inhaled foreign bodies in the period from June 2016 to June 2021, the medical records of patients who underwent bronchoscopy for suspected neglected foreign body aspiration will be reviewed. Assessment of different pictures of clinical presentations by reviewed symptoms and signs for the cases.
Measured: 3 months from August to December 2021
Determination of types of complications in neglected inhaled foreign body.
This is a retrospective study that will be conducted in our tertiary center "Sohag University Hospital", will include cases of neglected inhaled foreign bodies in the period from June 2016 to June 2021, the medical records of patients who underwent bronchoscopy for suspected neglected foreign body aspiration will be reviewed. Determination of types of complications in neglected inhaled foreign body.
Measured: 3 months from August to December 2021
Determination of different types of management plans in neglected inhaled foreign body.
This is a retrospective study that will be conducted in our tertiary center "Sohag University Hospital", will include cases of neglected inhaled foreign bodies in the period from June 2016 to June 2021, the medical records of patients who underwent bronchoscopy for suspected neglected foreign body aspiration will be reviewed. Determination of different types of management plans by rigid or flexible bronchoscopic findings, including the type and the location of the foreign body
Measured: 3 months from August to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Foreign Body; InhalationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mohamed Ahmed, Sohag University
- Investigators
- Abdel-Mateen M Abd ElLateef, professor, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988113
- Sponsor's protocol ID
- Soh-Med-21-07-14
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adjeso T, Damah MC, Murphy JP, Anyomih TTK. Foreign Body Aspiration in Northern Ghana: A Review of Pediatric Patients. Int J Otolaryngol. 2017;2017:1478795. doi: 10.1155/2017/1478795. Epub 2017 Oct 1.
PubMed 29098005Lin L, Lv L, Wang Y, Zha X, Tang F, Liu X. The clinical features of foreign body aspiration into the lower airway in geriatric patients. Clin Interv Aging. 2014 Sep 24;9:1613-8. doi: 10.2147/CIA.S70924. eCollection 2014.
PubMed 25284994Salih AM, Alfaki M, Alam-Elhuda DM. Airway foreign bodies: A critical review for a common pediatric emergency. World J Emerg Med. 2016;7(1):5-12. doi: 10.5847/wjem.j.1920-8642.2016.01.001.
PubMed 27006731
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presentation And Management Of Neglected Inhaled Foreign Body At Sohag University Hospital
- ClinicalTrials.gov ID
- NCT04988113
- Acronym / sponsor ID
- Soh-Med-21-07-14
- Conditions
- Foreign Body; Inhalation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 3 Aug 2021 (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.
Delayed presentation is not uncommon in children and may have been treated as asthma due to associated with low-grade cough and noisy breathing.
Late diagnoses of foreign body aspiration were defined as occurring beyond 3 days after the aspiration of the foreign body, or onset of symptoms.
Undiagnosed foreign body aspiration can cause mechanical effects, chemical reactions, and the most common complications were pneumonia, asthma, lung collapse, bronchiectasis, emphysema, mediastinal shift, atelectasis and lung abscess. Long-term presence of FBs in the bronchus may lead to bronchial stenosis
Detailed description
A foreign body is an endogenous or exogenous substance, different from the anatomy of the site where it is found. Chevalier Jackson defined a foreign body as "an object or a substance that is foreign to its location".
Aspiration of a foreign body (FB) is a potentially life-threatening emergency and 75% of cases occur in children younger than 3 years of age, due to the absence of molar teeth, underdeveloped swallowing coordination and the tendency to talk and play while eating .
However, foreign body aspiration does happen in adults and elderly people as well.
Obtaining a good history plays a vital role in effectively diagnosing a foreign body aspiration. Three clinical phases of aspiration of foreign bodies are recognized: The first stage is the impaction of the foreign body and entitled "penetration syndrome," defined as a sudden onset of choking and intractable cough with or without vomiting.
In the second stage, these symptoms diminish as the foreign body settles into a stationary location and the tracheoesophageal reflexes tire out; this asymptomatic stage can last hours to weeks, which may delay diagnosis. In the third phase, Complications occur (also defined as Complications phase), when obstruction, erosion or infection cause pneumonia, atelectasis, abscess or fever. The first presentation of the condition may actually represent a complication of inhaled foreign body.
Delayed presentation is not uncommon in children and may have been treated as asthma due to associated with low-grade cough and noisy breathing.
Late diagnoses of foreign body aspiration were defined as occurring beyond 3 days after the aspiration of the foreign body, or onset of symptoms.
Undiagnosed foreign body aspiration can cause mechanical effects, chemical reactions, and the most common complications were pneumonia, asthma, lung collapse, bronchiectasis, emphysema, mediastinal shift, atelectasis and lung abscess. Long-term presence of FBs in the bronchus may lead to bronchial stenosis.
Neglected foreign bodies in the respiratory tract may occur due to misdiagnosis by the fellow professionals and pediatricians when FBs in the upper tracheal airway produce symptoms similar to those of viral subglottic croup or due to lack of typical symptoms and signs. The most common symptoms and signs of FBA, namely coughing, wheezing, and decreased air entry, can easily be overlooked by bronchial asthma or pneumonia. Parental negligence, not conclusive chest radiographs, and false negative bronchoscopic findings are other blamed factors
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were diagnosed with neglected inhaled foreign body who underwent bronchoscopy in sohag university hospital
Key inclusion criteria (1 listed)
- Patients who were diagnosed with neglected inhaled foreign body who underwent bronchoscopy in sohag university hospital, all ages, both Gender.
Key exclusion criteria (1 listed)
- Patients who were diagnosed with recent inhaled foreign body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of different pictures of clinical presentations in neglected inhaled foreign body.
Time frame: 3 months from August to December 2021
This is a retrospective study that will be conducted in our tertiary center "Sohag University Hospital", will include cases of neglected inhaled foreign bodies in the period from June 2016 to June 2021, the medical records of patients who underwent bronchoscopy for suspected neglected foreign body aspiration will be reviewed. Assessment of different pictures of clinical presentations by reviewed symptoms and signs for the cases.
Determination of types of complications in neglected inhaled foreign body.
Time frame: 3 months from August to December 2021
This is a retrospective study that will be conducted in our tertiary center "Sohag University Hospital", will include cases of neglected inhaled foreign bodies in the period from June 2016 to June 2021, the medical records of patients who underwent bronchoscopy for suspected neglected foreign body aspiration will be reviewed. Determination of types of complications in neglected inhaled foreign body.
Determination of different types of management plans in neglected inhaled foreign body.
Time frame: 3 months from August to December 2021
This is a retrospective study that will be conducted in our tertiary center "Sohag University Hospital", will include cases of neglected inhaled foreign bodies in the period from June 2016 to June 2021, the medical records of patients who underwent bronchoscopy for suspected neglected foreign body aspiration will be reviewed. Determination of different types of management plans by rigid or flexible bronchoscopic findings, including the type and the location of the foreign body
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 29098005Adjeso T, Damah MC, Murphy JP, Anyomih TTK. Foreign Body Aspiration in Northern Ghana: A Review of Pediatric Patients. Int J Otolaryngol. 2017;2017:1478795. doi: 10.1155/2017/1478795. Epub 2017 Oct 1.
- Background: PubMed 25284994Lin L, Lv L, Wang Y, Zha X, Tang F, Liu X. The clinical features of foreign body aspiration into the lower airway in geriatric patients. Clin Interv Aging. 2014 Sep 24;9:1613-8. doi: 10.2147/CIA.S70924. eCollection 2014.
- Background: PubMed 27006731Salih AM, Alfaki M, Alam-Elhuda DM. Airway foreign bodies: A critical review for a common pediatric emergency. World J Emerg Med. 2016;7(1):5-12. doi: 10.5847/wjem.j.1920-8642.2016.01.001.
- 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.
Mostafa A Mohamed, professor contact
Abdel-Mateen M Abd ElLateef, professor study chair
Sohag 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 Foreign Body; Inhalation, run by Sohag University 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 1 inclusion and 1 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 3 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah M Ahmed, resident (01098720110, abdallah.ahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of different pictures of clinical presentations in neglected inhaled foreign body. (time frame: 3 months from August to December 2021). The study lists 3 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 NCT04988113, which also lists 3 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 3 Aug 2021.