Determining the effect of PEEP (Positive End-Expiratory Pressure )on the amount of bleeding and respiratory components in patients undergoing rhinoplasty
Design
In this study, 68 patients undergoing rhinoplasty were randomly assigned to two equal groups using random generator program and the patients code is packed in packets with letters A and B.
Settings and conduct
Participants and outcome evaluators are blind in this study. During surgery, patients receive PEEP 5 or zero depending on their contents.
Participants/Inclusion and exclusion criteria
18 to 40 years old patients referred to Amir-Al-Momenin hospital for Rhinoplasty in 1396 are participate in this study and patients that use anticoagulative drugs and Aspirin or alcohol and substance abusers and allergic patients to anesthetics drugs and patients with coronary heart or pulmonary diseases are excluded.
Intervention groups
1- patients receive 5CmH2o PEEP
2- patients receive no PEEP
Main outcome variables
amount of bleeding and respiratory Components
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140310016917N4
Registration date:2018-01-01, 1396/10/11
Registration timing:registered_while_recruiting
Last update:2018-01-01, 1396/10/11
Update count:0
Registration date
2018-01-01, 1396/10/11
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-30, 1396/10/09
Expected recruitment end date
2018-01-29, 1396/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Influence of Positive End-Expiratory Pressure on Intraoperative Bleeding and respiratory parameters in Rhinoplasty
Public title
The Influence of Positive End-Expiratory Pressure in Rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 40 years old patients
patients referred to Amir-Al-Momenin hospital for Rhinoplasty in 1396
Exclusion criteria:
use of anticoagulative drugs and Aspirin
alcohol and substance abuse
allergic to anesthetics drugs
coronary heart or pulmonary diseases
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned random sequences using the Random Generator program to the two groups and are packed in packets with letters A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
After random division, the names are in the envelopes packed with letters A and B. Assignment of patients is based on sequences determined by the technician. study is Double-blind by patients and outcome evaluator.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan university of Medical Sciences
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193893345
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
IR.GUMS.REC.1395.400
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Volume of soaked blood
Timepoint
At the end of operation
Method of measurement
Suction machine
2
Description
Weight of sterile gases
Timepoint
At the end of operation
Method of measurement
Weighing scale
Secondary outcomes
1
Description
Respiratory components
Timepoint
Initiation , every 30 minutes and at the end of operation
Method of measurement
Anesthesia machine
Intervention groups
1
Description
Control group: No Positive End-Expiratory Pressure (PEEP) during surgery
Category
Prevention
2
Description
Intervention group: PEEP 5 CmH2O
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-al-Momenin Hospital
Full name of responsible person
Ali Ashraf
Street address
17- Shahrivar Street
City
Rasht
Province
Guilan
Postal code
4193893345
Phone
+98 13 3322 5242
Email
Draliashraf@yahoo.fr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193893345
Phone
+98 13 3333 6394
Email
Nemati@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Anesthesiologist/ Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
Draliashraf@yahoo.fr
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Anesthesiologist/ Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3334 4812
Email
Draliashraf@yahoo.fr
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Anesthesiologist/ Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
aliashraf@gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The final outcome of the study will be shared
When the data will become available and for how long
6 months after publish
To whom data/document is available
academic Researchers
Under which criteria data/document could be used
after sharing data and outcomes there is no limits for use.
From where data/document is obtainable
Dr Ali Ashraf
draliashraf@yahoo.fr
What processes are involved for a request to access data/document