Determining the amount of exhaled carbon dioxide and the percentage of peripheral oxygen saturation
Design
This clinical trial will be performed on 200 patients with a control group in parallel and single-blind groups. Assignment of patients in each group based on simple randomization, phase 1 with the help of randomization website, and number assignment to patients will be done.
Settings and conduct
This study is performed in torfeh hospital with informed consent, under local anesthesia and sedation for blepharoplasty surgery. Based on simple randomization, one side of the blind is divided into two groups of 100 people by computer. In group A, a new oxygenation device is used and in group B, nasal cannula is used. In both groups, the oxygen flow is 4 liters per minute.Etco2 by capnograph and Spo2 via pulse oximetry are measured.
Participants/Inclusion and exclusion criteria
American society of Anesthesiologists (ASA) class 1 to 2 will be included and patients with chronic pulmonary, cardiovascular, renal, and sever chest deformity or patients without the possibility of cooperation such as language problems or deafness, psychiatric disorders and previous upper airway surgeries will be excluded.
Intervention groups
100 blepharoplasty surgery patients under local anesthesia and sedation in the intervention group receive oxygen flow at the rate of 4 liters per minute from new oxygenation device.
Main outcome variables
End-Tidal CO2, Peripheral oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050379N3
Registration date:2022-05-15, 1401/02/25
Registration timing:registered_while_recruiting
Last update:2022-05-15, 1401/02/25
Update count:0
Registration date
2022-05-15, 1401/02/25
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
2022-05-10, 1401/02/20
Expected recruitment end date
2022-11-11, 1401/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prevention effect of new oxygenation device versus nasal cannula in increasing exhalation co2
Public title
The effect of New oxygenation device on respiratory function enhancment.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Local blepharoplasty surgery via intravenous sedation
Exclusion criteria:
Chronic pulmonary, cardiovascular, renal, hepatic dysfunction or psychiatric disorders.
Sever chest wall deformity.
Patients without the possibility of cooperation such as language problems or deafness.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
200 patients scheduled for blepharoplasty surgery by simple randomization located in two groups:nasal canulla and new oxygenation device .the method of randomization and concealment was as follows:we started from the number1 to 200 and assigned the odd numbers to the nasal canulla group and the even numbers to the new ventilation device.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher and the person conducting the measurement and data collection do not know the patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
The device was tested by studying cataract patients and had significant results and was accepted at the World Anesthesia Congress in Prague.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of medical science
Street address
Medical school, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velengak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.SBMU.MSP.REC.1400.680
Health conditions studied
1
Description of health condition studied
The preventive effect of new oxygenation device versus nasal canulla in increasing exhalation Co2
ICD-10 code
ICD-10 code description
موضوع ما بیماری نیست
Primary outcomes
1
Description
Measurement of End tidal co2 and peripheral oxygen saturation
Intervention group: Patients in intervention group (A) receive 4 liters per minute of oxygen by a new oxygenation device that is sterile, reusable and washable. The polylactic acid weighs 110 grams and then placed on the patient's chest and with complete cardio-respiratory monitoring (EKG, SPO2, End Tidal co2, BP, RR) the patient's hemodynamic status and with the Richmond questionnaire, sedation status of The onset of the operation is measured and recorded up to 10 minutes after the operation, then the results are given to a statistician to analyze the data are obtained. P-value less than 0.05 will be considered significant.
Category
Prevention
2
Description
Control group: Patients in this group (B) are traditionally treated using a disposable nasal cannula made by Supao Company with a flow of 4 liters per minute of oxygen.Capnotrack is attached to the nasal cannula and exhaled carbon dioxide is transferred to the capnograph, and as intervention group, complete cardio respiratory monitoring is performed.