Comparison the effect of Pressure-controlled inverse ratio ventilation during laryngeal mask airway anesthesia on ventilatory parameters
Design
Clinical trial with parallel, randomized, and single-blind groups on 80 patients. Sealed envelopes were used for randomization.
Settings and conduct
This study was performed in the Anesthesiology Research Center of Tabriz University of Medical Sciences. The operating room nurse, who chooses sealed envelopes will be blinded about patients groups.
Participants/Inclusion and exclusion criteria
All patients aged 20 to 70 years with ASA class one and two who undergo cataract surgery under general anesthesia using a laryngeal mask will be included in the study.
Intervention groups
Group 1: Compression ventilation group with normal ratio ratio of inhalation to exhalation 1 to 2), maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and after starting Respiratory rate with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of exhalation between 30 to 35 mm Hg will be changed as needed.
Group 2: Compression ventilation group with inverse ratio (ratio of inhalation to exhalation 1.5 to 1), the maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and then From the beginning of the number of breaths with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of the exhalation between 30 to 35 mm Hg will be changed as needed.
Effect of Pressure-controlled inverse ratio ventilation during laryngeal mask airway anesthesia on ventilatory parameters
Public title
Pressure-controlled inverse ratio ventilation during laryngeal mask airway anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class one and two
Candidate for cataract surgery under general anesthesia using laryngeal mask
Exclusion criteria:
Perform surgery under local anesthesia
Lung disease
BMI > 30 kg/m2
Patients with obstructive sleep apnea
Patients with a history of gastroesophageal reflux
Reluctance to participate in the study
Age under 20 years
Age over 70 years
People with mental disabilities
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be using sealed envelopes, of which 80 envelopes will be selected in total and will be divided into two groups of 40, including groups A and B. Envelopes will be selected by the operating room nurse who is blind to the study groups. Group A will be the usual pressure ventilation group, group B will be the reverse pressure ventilation group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The operating room nurse, who chooses sealed envelopes, will be blinded about patients groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.TBZMED.REC.1398.708
Health conditions studied
1
Description of health condition studied
Pressure-controlled inverse ratio ventilation during laryngeal mask airway anesthesia
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Maximum airway pressure
Timepoint
1, 5, 10 and 20 minutes after the start of anesthesia
Method of measurement
Ventilator device monitor
2
Description
airway dynamic compliance
Timepoint
1, 5, 10 and 20 minutes after the start of anesthesia
Method of measurement
Ventilator device monitor
3
Description
expiratory volume of exhalation
Timepoint
1, 5, 10 and 20 minutes after the start of anesthesia
Method of measurement
Ventilator device monitor
4
Description
arterial blood oxygen saturation
Timepoint
1, 5, 10 and 20 minutes after the start of anesthesia
Method of measurement
Ventilator device monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Compression ventilation group with normal ratio ratio of inhalation to exhalation 1 to 2), maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and after starting Respiratory rate with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of exhalation between 30 to 35 mm Hg will be changed as needed.
Category
N/A
2
Description
Intervention group: Compression ventilation group with inverse ratio (ratio of inhalation to exhalation 1.5 to 1), the maximum airway pressure will be adjusted so that the current volume of 6 ml/kg based on the ideal body weight is delivered to the patient's lungs and then From the beginning of the number of breaths with 8 to 10 per minute, then the number of breaths to maintain carbon dioxide at the end of the exhalation between 30 to 35 mm Hg will be changed as needed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikoukari hospital
Full name of responsible person
Dr. Jafar Rahimi
Street address
Nikukari hospital, in front of 11 Janbazan Police Station, Abbasi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7330
Email
nikohosp@tbzmed.ac.ir
Web page address
https://nikukarihosp.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ata Mahmoudpour
Street address
Faculty of medicine, near Imam-Reza hospital, Gholgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3336 4667
Email
amahmoodpoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahkam Rezvani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Unit 10, First enterance, Negin 2 apartment, Kouhsar Blvd., Roshdiyeh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3668 6556
Fax
Email
mahkam.rezvanii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahkam Rezvani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Unit 10, First enterance, Negin 2 apartment, Kouhsar Blvd., Roshdiyeh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3668 6556
Fax
Email
mahkam.rezvanii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahkam Rezvani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Unit 10, First enterance, Negin 2 apartment, Kouhsar Blvd., Roshdiyeh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3668 6556
Fax
Email
mahkam.rezvanii@gmail.com
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.