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Comparison the effect Of Pressure On The Nose By Nose Stuck With The Gas Pressure On The Control Of Nose Bleeding In Patients Presenting To The Emergency Department With Complaints Of Epistaxis

Protocol summary

Summary
The Aim Of The Study: Determine The Effect Of Pressure On The Nose By Nose Stuck With The Gas Pressure On The Control Of Nose Bleeding In Patients Presenting To The Emergency Department With Complaints Of Epistaxis Study Design: Randomized, Single-Blind, Two-Center, Phase One Trial Study Population: All Patients Presenting To The Emergency Department With Complaints Of Epistaxis Inclusion Criteria The Patient Is Admitted With Complaints Of Epistaxis. And Must Have Active Bleeding At The Time Of The Study. Age Older Than 16 Years. Epistaxis Of The Anterior. Exclusion Criteria Were Bleeding Caused By Trauma Or Surgical Procedures. Anticoagulants Drugs Or Bleeding Disorders In Patients (Platelet Count Less Than 100,000, Hemophilia, INR Greater Than 1.5, Hematologic Malignancies), Intervention To Control Bleeding During 6 Months Ago (Cautery, Tampons, Local Treatment). Posterior Epistaxis. Hemodynamic Instability. Upper Respiratory Tract Infection. Accompanied By A Significant Other Complaints (Eg, Chest Pain). Lack Of Patient Consent To Participate In The Study. Deviation Of The Nasal Septum. Target Sample Size: 60 Patients. Intervention Use Nose Stuck (Intervention Group) Nasal Pressure By The First And Second Fingers On Dominant Hand (The Control Group), After 15 Minutes Epistaxis Patient's Condition Will Be Assessed. Outcome Study: Bleeding Is stopped. After Wiping The Nose With A Tissue, Blood Stain On It. Without The Flow Of Blood, Oozing Bleeding Obvious. The Rest Of The Bloodstream But To A Lesser Extent From The Time Of Referral. Bleeding Unchanged From The Time Of The Visit.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201078640N1
Registration date: 2016-03-13, 1394/12/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Majid Hajimaghsoudi
Name of organization / entity
Shahid Sadoughi University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
hajimaghsoudi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Scienses
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect Of Pressure On The Nose By Nose Stuck With The Gas Pressure On The Control Of Nose Bleeding In Patients Presenting To The Emergency Department With Complaints Of Epistaxis
Public title
Comparison Of Two Methods In The Treatment Of Epistaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: For Patient Is Admitted With Complaints Of Epistaxis, And Must Have Active Bleeding At The Time Of The Study. Age Older Than 16 Years. Epistaxis Must Be Anterior Type. Exclusion Criteria Were Bleeding Caused By Trauma Or Surgical Procedures. Anticoagulants Drugs Or Bleeding Disorders In Patients (Platelet Count Less Than 100,000, Hemophilia, INR Greater Than 1.5, Hematologic Malignancies), Intervention To Control Bleeding During 6 Months Ago (Cautery, Tampons, Local Treatment). Posterior Epistaxis. Hemodynamic Instability. Upper Respiratory Tract Infection. Accompanied By A Significant Other Complaints (Eg, Chest Pain). Lack Of Patient Consent To Participate In The Study. Deviation Of The Nasal Septum.
Age
From 16 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Scienses
Street address
Centeral Organization of Shahid Sadoughi University of Medical Scienses, Bahonar Squr, Yazd
City
Yazd
Postal code
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
IR.SSU.MEDICINE.REC.1394427

Health conditions studied

1

Description of health condition studied
Epistaxis
ICD-10 code
R04.4
ICD-10 code description
Haemorrhage from nose Nosebleed

Primary outcomes

1

Description
Resolve Bleeding
Timepoint
15 minutes later
Method of measurement
Direct Inspection

Secondary outcomes

1

Description
ENT specialist consult
Timepoint
At discharge time
Method of measurement
Case inspection

2

Description
Patient satisfaction
Timepoint
At discharge time
Method of measurement
upon likert scale

3

Description
Need for more intervention
Timepoint
at discharge time
Method of measurement
case inspection

4

Description
Recurrenc of epistaxis
Timepoint
24 houres after discharge from emergency unit
Method of measurement
Interview with patient

5

Description
Care duration in emergency unit
Timepoint
After discharge
Method of measurement
Since the establishment of emergency cases until discharge in minutes

Intervention groups

1

Description
In the intervention group, we put the nose stuck on the patient's nose and after 15 min evaluate epistaxis scale compared to the initial state.
Category
Treatment - Other

2

Description
In the control group, patient wanted to hold his/her nose tightly and after 15 min evaluate epistaxis scale compared to the initial state.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Ranamoun Hospital
Full name of responsible person
Street address
City
Yazd

2

Recruitment center
Name of recruitment center
Shahid Sdoughi Hospital
Full name of responsible person
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Shahid Sadougi University of Medical Scienses, Bahonar square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Scienses
Full name of responsible person
Hosein Amiri Largani
Position
Resident in Emergency Medicine
Other areas of specialty/work
Street address
Shahid Doctor Rahnemoon Hospital, Farrokhi Street, Yazd
City
Yazd
Postal code
Phone
+98 35 3626 8111
Fax
Email
amirilargani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Scienses
Full name of responsible person
Hosein Amiri Largani
Position
Resident in Emergency Medicine
Other areas of specialty/work
Street address
Shahid Rahnemoon Hospital, Farrokhi Ave, Yazd
City
Yazd
Postal code
Phone
+98 35 3626 8111
Fax
Email
amirilargani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Scienses
Full name of responsible person
Hosein Amiri Largani
Position
Resident in Emergency Medicine
Other areas of specialty/work
Street address
Shahid Doctor Rahnemoon Hospital, Farrokhi Ave, Yazd
City
Yazd
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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