The comparison effectiveness Of Farsan Ventilation Equipment (F V E) with nasal cannula In Oxygenation and End-tidal Carbon dioxide During Local Cataract Surgery.
The main aim of this study is to assess End-tidal co2 (Etco2) among local cataract patients .
Design
This study will be performed on 200 patients, 100 patients in each group in parallel and bilaterally. The assignment of patients in each group will be based on simple randomization with the help of randomization website and number assignment to patients.
Settings and conduct
This study is performed in a one-way hospital with informed consent, under local anesthesia and sedation. Patients are randomly divided into two groups of 100 people. After the ophthalmologist injects tetracaine drops into the eye, patients are placed under local anesthesia. After 3 minutes in the intervention group, the Farsan ventilation device was placed on the patient's chest so that the oxygen outlet was located at a distance of 1 cm from the patient's nose. In the control group, an oxygen cannula is used. The oxygen flow in both groups is 4 liters per minute.
Participants/Inclusion and exclusion criteria
American Society of Anesthesiologists (ASA) class 1 to 3 will be included and
Patients with severe chest deformity, uncooperative patients such as language barrier, deafness chronic pulmonary , cardiovascular, renal, and psychiatric disorders and previous upper airway surgeries will be excluded
Intervention groups
100 cataract surgery patients under local anesthesia and sedation in the intervention group receive oxygen flow at the rate of four liters per minute from the Farsan ventilation device.
Main outcome variables
End tidal carbon dioxide, percentage of hemoglobin o2 saturation,Respiratory rate ,Blood pressure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050379N2
Registration date:2022-03-05, 1400/12/14
Registration timing:registered_while_recruiting
Last update:2022-03-05, 1400/12/14
Update count:0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Hamidreza Azizifarsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
h.faresani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effectiveness Of Farsan Ventilation Equipment (F V E) with nasal cannula In Oxygenation and End-tidal Carbon dioxide During Local Cataract Surgery.
Public title
The effect of farsan ventilation Device on respiratory function enhancement.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Topical cataract surgery via intravenous sedation
Patients with ASA(American Society of Anesthesia) CLASS1-3
Exclusion criteria:
severe chest wall deformity
chronic pulmonary, cardiovascular, renal and hepatic dysfunction or psychiatric disorders
previous upper Airway surgeries
Patients without the possibility of cooperation such as language problems or deafness
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
200 patients scheduled for cataract surgery by simple randomization located in two groups nasal canulla and farsan. The method of randomization and concealment was as follows: we started from the number 1 to the number 200 and assigned the odd numbers to the nasal cannula group and the even numbers to the Farsan ventilation device.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of the type of oxygen device, nasal cannula, or new device used by the anesthesiologist during surgery and is not in sight, and the person performing the measurements and data collection does not know the patient group.
Placebo
Not used
Assignment
Parallel
Other design features
This equipment has never been invented anywhere and is unique.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of ophthalmic research center Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.SBMU.ORC.REC.1400.004
Health conditions studied
1
Description of health condition studied
The comparison effectiveness of Farsan ventilation equipment with Nasal cannula in oxygenation and End-tidal co2 during topical cataract surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of End-tidal carbon dioxide
Timepoint
From 0 to 40 minutes after the intervention
Method of measurement
Capnography
Secondary outcomes
1
Description
Patient Oxygenation
Timepoint
From 0 to 40 minutes after the intervention
Method of measurement
Pulse oxymeter
2
Description
Assesment of Blood pressure and respiratory rate
Timepoint
From 0 to 40 minutes after the intervention
Method of measurement
Non invasive blood pressure monitoring
3
Description
Assesment of patients anexiety
Timepoint
before and after cataract surgery
Method of measurement
State-Trait Anxiety Inventory (STAI)
Intervention groups
1
Description
Intervention group: Patients in the intervention group by Farsan ventilation machine, which is used several times, washable and sterile, which is not made in a special factory and is designed by the researchers of this project and produced by several medical engineers in a workshop.This device is made of polylactic acid and weighs 110 grams. This device is connected to a 4-liter flow oxygen source through a plastic pipe. The air reaches the patient's nose through a connecting tube. This device is also used for patients up to 10 minutes after surgery. The carburetor connected to the device transfers carbon dioxide to the capnograph and the amount of inhaled carbon dioxide is recorded in both intervention and control groups. Patients are unaware of the type of device. The researcher and analyst do not know the statistics. This device has already been associated with good results in the study of phase 1.
Category
Prevention
2
Description
Control group: Patients in this group are treated with a traditional method using an oxygen cannula made by Supa Company and disposable connected to the oxygen source of an anesthesia machine with a flow of 4 liters of oxygen. This cannula is used for patients up to 10 minutes after the operation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Torfeh Ophthalmology Hospital
Full name of responsible person
Hamidreza Azizi Faresani
Street address
Ebne- sina street, baharestan square, Tehran
City
Tehran
Province
Tehran
Postal code
1149847514
Phone
+98 21 7762 6556
Fax
+98 21 7753 4171
Email
torfehospital@sbmu.ac.ir
Web page address
https://tomc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research Afshin Zarghi
Street address
Bldg No.2, Shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
استان تهران، شهر تهر
Phone
+98 21 2243 9770
Fax
Email
intl_office@sbmu.ac.ir
Web page address
Grant name
Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences Dr. Afshin Zarghi
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamidreza Azizi farsani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
No.1, Shahid Lamee st, Faraze jonobi, Koye Faraz, Saadatabad, Tehran