Evaluation of the efficacy of laryngeal mask Airway (LMA) compared to endotracheal tube (ETT) in thoracic and abdominal surgeries for more than 2 hours under general anesthesia in Fatemeh hospital.
Design
This study is a randomized, double-blind clinical trial with a sample size of 100, which is randomly assigned to two groups. On the airway the first group is wearing a laryngeal mask. In the second group, the endotracheal tube is inserted.
Settings and conduct
In this study, 100 patients undergoing thoracic and abdominal surgery will be divided into two groups including laryngeal mask and endotracheal tube and all patients will receive the same premedication and induction. In the first group of LMA the appropriate size is 3, 4 or 5 according to the recommendation of the manufacturer with standard placement. In the second group, ETTs are 7 or 7.5 for female patients and 7.5 or 8 for male patients. All patients receive propofol during surgery. Both groups were studied for variables such as age, sex, Malampathy Class and BMI. The study was performed in Fatemeh Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Physical Status Classification System 1 or 2
Patient satisfaction to participate in the study
Age range between 25 and 60 years,
Exclusion criteria: Patient dissatisfaction to participate in the study, Patients not fasting, Latex sensitivity
History of colds in the last 10 days
Intervention groups
Intervention group one: Applying laryngeal mask (LMA) to airway management of patients undergoing general anesthesia for thoracic and abdominal plastic surgery
Intervention group II: Use of endotracheal tube (ETT) for airway management of patients undergoing general anesthesia for thoracic and abdominal plastic surgery
Main outcome variables
Damage to the airway, Easier placement, Bronchospasm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110513006465N2
Registration date:2020-03-14, 1398/12/24
Registration timing:registered_while_recruiting
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Seyed Alireza Seyed Siamdoust
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 1749
Email address
siamdoust.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of laryngeal mask Airway (LMA) compared to endotracheal tube (ETT) in thoracic and abdominal surgeries general anesthesia.
Public title
Evaluation of the efficacy of laryngeal mask Airway (LMA) compared to endotracheal tube (ETT) in thoracic and abdominal surgeries for under general anesthesia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA Physical Status Classification System 1 or 2
Patient satisfaction to participate in the study
Age range between 25 and 60 years
Exclusion criteria:
Patient dissatisfaction to participate in the study
Patients not fasting
Latex sensitivity
History of colds in the last 10 days
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a double-blind randomized clinical trial in which the number of patients is determined according to the sample size formula and using a simple randomization method, which uses a random number table for each patient. The code is given and patients are randomly assigned to two treatment groups, with random code selection.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients are not aware of the placement in the study groups, and the person who analyzes the information collected does not know the study groups and is given information in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.IUMS.FMD.REC.1398.539
Health conditions studied
1
Description of health condition studied
Thoracic Surgery
ICD-10 code
G54.3
ICD-10 code description
Thoracic root disorders, not elsewhere classified
Primary outcomes
1
Description
Effects on airway after intubation in anesthesia
Timepoint
During surgery and after surgery
Method of measurement
checkup
Secondary outcomes
1
Description
Sore Throat
Timepoint
After surgery
Method of measurement
Examination
Intervention groups
1
Description
Intervention group 1: LMA masks of suitable size 3, 4 or 5 as recommended by the manufacturer (manufactured by IranFormis) before surgery and once. LMA cuff slowly fills until sound Don't hear from Leak Cuff. The LMA cuff pressure is filled in by a pressure gauge of 30 to 40 cm.
Category
Treatment - Devices
2
Description
اntervention group 2: Placement of an endotracheal tube size 7 or 7/5 for female patients and size7/5 or 8 for male patients according to the recommendation of the manufacturer (production of teb tolid company) before surgery and once. The cuff is filled up to 25 mm Hg.