Comparison of endotracheal airway intubation and laryngeal mask (LMA) methods on respiratory parameters in patients undergoing elective orthopedic sugery
Reduction of respiratory complications in patients undergoing orthopedic surgery
Design
Clinical trial with two groups of 48 people with parallel groups (establishment of airway with Endotracheal tube and establishment of airway with laryngeal mask, blind bilateral, randomized using Random allocation software
Settings and conduct
The study will be performed at Hormozgan University of Medical Sciences. All patients will be admitted to the orthopedic ward before surgery will be reserved for all patients 2 units of blood. Preliminary tests will be requested for patients. All patients will receive 40mg of pantoprazole and 1 mg of lorazepam orally.
In the operating room, all patients are monitored by EKG and pulse oximetry and blood pressure control. Induction of anesthesia will be considered the same for all patients (propofol 2 mg / kg and atracurium 0.5 mg / kg). Then patients are placed in two groups : group 1 for endotracheal intubation (No. 7.5 for females and No. 8 for males) 3 minutes after injection of atracurium and ventilation with 100% oxygen and for group 2 of laryngeal mask is used with appropriate size based on weight of the patient . The duration of surgery and hemodynamic parameters in each group are recorded after airway establishment and at 1,3,5,10,15 minutes after intubation.
Participants/Inclusion and exclusion criteria
96 patients of both sexes aged 18-70 years with ASA I, II candidates for elective orthopedic surgery
No entry conditions:
History of COPD, Asthma, ILD, and Pulmonary fibrosis or active lung infection
Ejection fraction (EF) less than 40%, BMI > 35 kg / m2, Emergency surgery
Airway malformation
Intervention groups
The first group is a candidate for airway intubation
The second group nominates a laryngeal mask
Comparison of endotracheal airway intubation and laryngeal mask (LMA) methods on respiratory parameters in patients undergoing elective orthopedic sugery
Public title
Evaluation of the effect of endotracheal intubation and laryngeal mask on respiratory parameters
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 70 years ASA I, II candidate for elective orthopedic surgery under general anesthesia
Exclusion criteria:
History of COPD, asthma, ILD, and pulmonary fibrosis with active lung infection
EF fraction (less than 40%)
BMI > 35 kg / m2
Emergency surgery
Airway malformation
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In order to eliminate the bias caused by the patient's awareness or anesthesia assistant and evaluator of the results and its possible effect on the research result, the study is performed as a two-way blind and a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Random allocation was performed based on Random allocation software and based on that, the even numbers of the table were considered for airway intubation and the odd numbers of the table were considered for laryngeal mask placement. The numbers were placed in sealed envelopes and by someone other than the procedure Returned and based on that the airway was managed by an anesthesia assistant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee Of Hormozgan University Of Medical Sciences
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.HUMS.REC.1400.344
Health conditions studied
1
Description of health condition studied
Orthopedic patients
ICD-10 code
Z47
ICD-10 code description
Orthopedic aftercare
Primary outcomes
1
Description
Investigation of respiratory parameters
Timepoint
Evaluation of respiratory parameters at 1, 3, 5, 10 and 15 minutes after airway establishment
Method of measurement
Measurement of arterial oxygen saturation percentage by pulse oximetry device and End-tidal carbon dioxide(Etco2) via capnograph
Secondary outcomes
1
Description
Respiratory complications during surgary
Timepoint
Measurement of respiratory parameters such as blood oxygen saturation percentage (spo2) and end-tidal carbon dioxide (Etco2) at 1, 3, 5, 10 and 15 minutes after establishing airway
Method of measurement
Pulse oximetry and capnography device
Intervention groups
1
Description
Intervention group: Establishment of airway through endotracheal tube
Category
Treatment - Devices
2
Description
Control group: Establishment of airway through laryngeal mask (LMA)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Majid Vatankhah
Street address
Jomhuri Blvd., Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
m.vatankhah@hums.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Majid Vatankhah
Street address
Jomhuri Blvd., Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
m.vatankhah@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Timur Aghamlaei
Street address
Deputy of research and technology, East Side, Bandar Abbas Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 71 3333 5794
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
50
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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri BLV
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
m.vatankhah@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
m.vatankhah@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Vatankhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Email
m.vatankhah@hums.ac.ir
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
After confirming the publication of the article
To whom data/document is available
All Researchers
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Dr.Majid Vatankhah through email:m.vatankhah@hums.ac.ir
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.