- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151888
Hot Water Irrigation in Posterior Epistaxis
Evaluation of Nasal Hot Water Irrigation in the Management of Posterior Epistaxis
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients age: > 10 years.
- Failed first aid measures.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Epistaxis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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