Effect of Daily Administration of Nebulized Heparin on Prevention of Endotracheal Tube Blockage by Clot and Mucus Plug Compared to Normal Saline in Patients with Pneumonia
Effect of daily administration of nebulized heparin on prevention of endotracheal tube blockage by clot and mucus plug in patients with pneumonia
Design
This study was double blind clinical trial with parallel groups that using randomized block method and available sampling was performed among patients admitted in the ICU in two groups of intervention and control and the sample size in each group was 20 patients.
Settings and conduct
This Study Is Performed on 40 Patients with Pneumonia who Have Been Intubated and Admitted to the ICU of Imam Khomeini Hospital in Ahvaz. Patients Are Randomly Divided into Two Groups of 20 Patients. Patients with Inclusion Criteria After Randomization Procedures Receive Heparin Ampoules of 5000 Units per 1 Ml Mixed In 4 Cc Of Normal Saline 0.9% every 6 Hours as Nebulization through the Endotracheal Tube. This is done daily for up to 14 days. In the Same Way and in the Same amount in the Same Syringe, Which Is Distilled Water, We Nebulize the Patient in the Control Group
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with pneumonia who have been intubated and admitted to the ICU.Patients must have an apache score of less than 25.
Exclusion Criteria: Thrombocytopenia or a history of heparin-induced thrombocytopenia,Coagulation disorder with INR above 1.5
pregnant women, Any active bleeding and history of intracranial hemorrhage during the last 3 months
Intervention groups
The intervention group in our study includes patients who receive nebulized heparin.The control group in our study includes patients who receive a placebo that is normal saline
Main outcome variables
The degree of obstruction of the endotracheal tube by plug or bare mucus; Hypoxia; Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200821048470N1
Registration date:2020-10-12, 1399/07/21
Registration timing:registered_while_recruiting
Last update:2020-10-12, 1399/07/21
Update count:0
Registration date
2020-10-12, 1399/07/21
Registrant information
Name
Houshmand Hosseininezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 7410
Email address
hosseininezhad.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Daily Administration of Nebulized Heparin on Prevention of Endotracheal Tube Blockage by Clot and Mucus Plug Compared to Normal Saline in Patients with Pneumonia
Public title
"Effect of Nebulized Heparin in Patients with Pneumonia"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pneumonia who have been intubated and admitted to the ICU.
All patients have an apache score less than 25.
Exclusion criteria:
Thrombocytopenia or a history of heparin-induced thrombocytopenia
Coagulation disorder with INR above 1.5
pregnant women
Any active bleeding and history of intracranial hemorrhage during the last 3 months
Patients receiving anticoagulants
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Out of 40 Patients who Entered the Study by Random Block Method,Individuals are Randomly Assigned to Both Interventional and Non-interventional Groups (with placebo).Randomized numbers from 1 to 40 was produced with
a calculator, the first twenty numbers allocated to intervention group and the other twenty numbers allocated to control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Once the patients in the study groups have been identified, the drug and placebo are placed in the same syringes as they are in appearance, and thus patients will not be informed of the contents inside it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-02-19, 1398/11/30
Ethics committee reference number
IR.AJUMS.REC.1399.257
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
The degree of obstruction of the endotracheal tube by plug or bare mucus
Timepoint
On admission and daily
Method of measurement
Clinical Information Collection Form
2
Description
Hypoxia
Timepoint
On admission and daily
Method of measurement
Drop in arterial blood oxygen saturation to less than 90 or more than 4% of basal level after elimination of other common causes
3
Description
Infection
Timepoint
On admission and daily
Method of measurement
New VAP event based on different clinic or graph with primary lung infection
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group, patients receive 5,000 units of heparin ampoules per 1 ml mixed with 4 cc of 0.9% normal saline every 6 hours as a nebulization through a tracheal tube. This is done daily for up to 14 days or until the patient becomes extubate or dies.
Category
Treatment - Drugs
2
Description
Control group: in this group, patients after randomization, receive 5 cc of normal saline 0.9% through endotracheal tube nebulization every 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Hooshmand Hosseininezhad
Street address
Imam Khomeini Hospital.,Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 5574
Email
hosseininezhad.h@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Jundishapur University of Medical Sciences, Chancellor for Research and Technology Development, Golestan Blvd., Golestan Town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8286
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hooshmand Hosseininezhad
Position
Pulmonary fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital., Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 5574
Email
hosseininezhad.h@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Hamid Borsi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital., Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 5574
Email
borsi-h@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hooshmand Hosseininezhad
Position
Fellowship ( sub-specialist assistant)
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital.,Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3221 5574
Email
karami.9926@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic Data and the Result of Clinical Trial
When the data will become available and for how long
access begins one year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Research on related issues
From where data/document is obtainable
Houshmand Hosseininezhad
What processes are involved for a request to access data/document