EpistaxisNCT04151888
Hot Water Irrigation in Posterior Epistaxis
An observational study of Epistaxis, run by Assiut University.
Trial summary
This study was aimed to assess the efficacy and factors affecting the success of hot water irrigation in management of posterior epistaxis. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Epistaxis
- What is being tested?
- Foley catheter
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2020to 30 Jun 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study is including patients with spontaneous posterior epistaxis referred to ENT Department, Assiut University Hospital. .
Who may be able to join
- patients age: > 10 years.
- Failed first aid measures.
Who cannot join
- Patients age < 10 years old.
- Patients with anterior epistaxis.
- Patients presented with hemorrhagic shock.
- Patients presented with post-surgical bleeding.
- Suspected nasal pathology e.g tumors or trauma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Nasal Hot Water Irrigation in the Management of Posterior Epistaxis
This study was aimed to assess the efficacy and factors affecting the success of hot water irrigation in management of posterior epistaxis.
Read the detailed description
Epistaxis has been reported to occur in up to 60% of general population.This condition has incidence peaks at ages younger than 10 years and older than 50 years. Epistaxis appears to occur more in males than females . In rare cases massive nasal bleeding can lead to death.
Nasal bleeding usually responds to first aid measures such as compression.When Epistaxis doesn't respond to simple measures. The source of bleeding should be located and treated appropriately. Treatment options to be considered include topical vasoconstriction, chemical cautery, electrocautery, nasal packing, posterior gauze packing, use of balloon system, and arterial ligation or embolization. Hospital admission should be considered with patients with comorbid conditions or complication of blood loss.
Nasal Hot water irrigation was first described by Guice in 1878 as an effective method of treating severe life-threatening epistaxis. However, the technique was already in use by nineteenth century obstetricians as a method of treating postpartum bleeding . In the second half of the twenties century, nasal packing products and the development of endoscopic sinus surgery almost completely replaced the irrigation technique as treatment for posterior epistaxis. However, Stangerup et al. (1996) have demonstrated that hot water irrigation, using temperatures of up to 50°C, produces vasodilation and oedema of the nasal mucosa without the risk of necrosis and accelerating the clotting cascade.
Hot water irrigation had a higher success rate (55 %) in treating posterior epistaxis, compared with nasal packing (44 %) .Using a modified irrigation technique, was able to stop bleeding permanently in up to 82 %of cases of posterior epistaxis, including patients receiving antiplatelet agents or anticoagulants . During a follow-up period of four to 24 months. Furthermore, successful hot water irrigation was associated with less nasal trauma, significantly less pain, fewer surgical procedures and avoidance of a hospital stay.
- Conditions
- Epistaxis
- Being tested
- Foley catheter
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheterDevice
Thin sterile tube will be inserted in choana
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of hot water irrigation in management of posterior epistaxis
Observation of the patients for 24 hrs after controlling of posterior epistaxis using hot water irrigation if it can control posterior epistaxis or not and this will be confirmed by using coagulation profile and complete blood count
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start30 Jan 2020 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RT Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151888
- Sponsor's protocol ID
- Epistaxis
- Status last verified
- Nov 2019
- First submitted
- 18 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Randall DA, Freeman SB. Management of anterior and posterior epistaxis. Am Fam Physician. 1991 Jun;43(6):2007-14.
PubMed 2042544
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nasal Hot Water Irrigation in the Management of Posterior Epistaxis
- ClinicalTrials.gov ID
- NCT04151888
- Acronym / sponsor ID
- Epistaxis
- Conditions
- Epistaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2020 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 5 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.
This study was aimed to assess the efficacy and factors affecting the success of hot water irrigation in management of posterior epistaxis.
Detailed description
Epistaxis has been reported to occur in up to 60% of general population.This condition has incidence peaks at ages younger than 10 years and older than 50 years. Epistaxis appears to occur more in males than females . In rare cases massive nasal bleeding can lead to death.
Nasal bleeding usually responds to first aid measures such as compression.When Epistaxis doesn't respond to simple measures. The source of bleeding should be located and treated appropriately. Treatment options to be considered include topical vasoconstriction, chemical cautery, electrocautery, nasal packing, posterior gauze packing, use of balloon system, and arterial ligation or embolization. Hospital admission should be considered with patients with comorbid conditions or complication of blood loss.
Nasal Hot water irrigation was first described by Guice in 1878 as an effective method of treating severe life-threatening epistaxis. However, the technique was already in use by nineteenth century obstetricians as a method of treating postpartum bleeding . In the second half of the twenties century, nasal packing products and the development of endoscopic sinus surgery almost completely replaced the irrigation technique as treatment for posterior epistaxis. However, Stangerup et al. (1996) have demonstrated that hot water irrigation, using temperatures of up to 50°C, produces vasodilation and oedema of the nasal mucosa without the risk of necrosis and accelerating the clotting cascade.
Hot water irrigation had a higher success rate (55 %) in treating posterior epistaxis, compared with nasal packing (44 %) .Using a modified irrigation technique, was able to stop bleeding permanently in up to 82 %of cases of posterior epistaxis, including patients receiving antiplatelet agents or anticoagulants . During a follow-up period of four to 24 months. Furthermore, successful hot water irrigation was associated with less nasal trauma, significantly less pain, fewer surgical procedures and avoidance of a hospital stay.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is including patients with spontaneous posterior epistaxis referred to ENT Department, Assiut University Hospital. .
Key inclusion criteria (2 listed)
- patients age: > 10 years.
- Failed first aid measures.
Key exclusion criteria (5 listed)
- Patients age < 10 years old.
- Patients with anterior epistaxis.
- Patients presented with hemorrhagic shock.
- Patients presented with post-surgical bleeding.
- Suspected nasal pathology e.g tumors or trauma.
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 |
|---|---|---|
| Foley catheterThin sterile tube will be inserted in choana | Device | – |
Primary outcome
Effect of hot water irrigation in management of posterior epistaxis
Time frame: 2 years
Observation of the patients for 24 hrs after controlling of posterior epistaxis using hot water irrigation if it can control posterior epistaxis or not and this will be confirmed by using coagulation profile and complete blood count
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Background: PubMed 2042544Randall DA, Freeman SB. Management of anterior and posterior epistaxis. Am Fam Physician. 1991 Jun;43(6):2007-14.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Epistaxis, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Rania Tharwat Fahmi, Resident doctor (01013743663, raniatharwat93@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of hot water irrigation in management of posterior epistaxis (time frame: 2 years). 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 NCT04151888, which also lists 1 linked publication.
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 5 Nov 2019.