Comparison of the effect of synchronized intermittent mandatory ventilation and pressure-regulated volume control on the rate of asynchrony in mechanically ventilated patients
To compare the effect of synchronized intermittent mandatory ventilation with pressure-regulated volume control on the rate of asynchrony in mechanically ventilated patients
Design
Phase III assessor-blind randomized placebo-controlled trial with parallel groups on 100 patients, randomization performed using a randomization table generated by the Random Allocation software
Settings and conduct
This study will be performed on 100 multiple trauma patients admitted to the ICU of Bandar Abbas Shahid Mohammadi Hospital. Patients will be randomized into two groups based on a randomization table. In intervention group 1 patients will receive synchronized intermittent mandatory ventilation with a respiratory rate of 10-15/min, tidal volume of 6 mg/kg, positive end-expiratory pressure of 5-7, pressure support of 10, and trigger sensitivity of 2-3 L and in the intervention group 2 patients will receive the pressure-regulated volume control (PRVC) mode of the ventilator. The rate of asynchrony will be evaluated by an individual unaware of patient grouping from the monitor and graph of the ventilator within 72 hours; therefore, the study will be assessor-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 15-70 years, mechanical ventilation, multiple trauma
Exclusion criteria: Hemodynamic instability, pneumothorax, pneumomediastinum
Intervention groups
Intervention group 1: Synchronized intermittent mandatory ventilation with a respiratory rate of 10-15/min, tidal volume of 6 mg/kg, positive end-expiratory pressure of 5-7, pressure support of 10, and trigger sensitivity of 2-3 L
Intervention group 2: The pressure-regulated volume control mode of the ventilator
Main outcome variables
Rate of asynchrony
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230702058640N1
Registration date:2023-07-04, 1402/04/13
Registration timing:prospective
Last update:2023-07-04, 1402/04/13
Update count:0
Registration date
2023-07-04, 1402/04/13
Registrant information
Name
Amirreza Talebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
matin.talebi12@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of synchronized intermittent mandatory ventilation and pressure-regulated volume control on the rate of asynchrony in mechanically ventilated patients
Public title
Rate of asynchrony in mechanically ventilated patients with synchronized intermittent mandatory ventilation versus pressure-regulated volume control on the
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15-70 years
Mechanical ventilation
Multiple trauma
Patients will be randomized into two groups using simple randomization with individuals as the unit of randomization and a randomization table produced by the Random Allocation software. An individual uninvolved in the study will write A or B on a card and put it in an opaque envelope. Then the associated number in the randomization table will be written on the back of the envelope. One envelope will be allocated to each patient in order of entrance to the study. Allocation concealment will be done using opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The rate of asynchrony will be recorded by an individual unaware of the mode of the ventilator based on the ventilator graph and monitor; therefore, the study will be assessor-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Approval date
empty
Ethics committee reference number
2
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Faculty of Medicine, across from Kargaran Sports Complex, Imam Hossein Blvd., Bandar Abbas, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
IR.HUMS.REC.1402.054
Health conditions studied
1
Description of health condition studied
Mechanical ventilation
ICD-10 code
Z51.8
ICD-10 code description
Encounter for other specified aftercare
Primary outcomes
1
Description
Rate of asynchrony
Timepoint
Within 72 hours of the intervention initiation
Method of measurement
Observation of early cycling, delayed cycling, ineffective triggering, and double triggering on the monitor of graph of the ventilator
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Synchronized intermittent mandatory ventilation with a respiratory rate of 10-15/min, tidal volume of 6 mg/kg, positive end-expiratory pressure of 5-7, pressure support of 10, and trigger sensitivity of 2-3 L
Category
Prevention
2
Description
Intervention group: The pressure-regulated volume control mode of the ventilator
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Amirreza Talebi
Street address
Shahid Mohammadi Hospital, Jomhuri Eslami Blvd., Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery for Research Hormozgan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
across from Kargaran Sports Complex, Imam Hossein Blvd., Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
teaghamolaei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research Hormozgan 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Amirreza Talebi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Fax
Email
matin.talebi12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Amirreza Talebi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Fax
Email
matin.talebi12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Amirreza Talebi
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Mohammadi Hospital, Jomhouri Eslami Blvd., Bandar Abbas, Hormozgan
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Fax
Email
matin.talebi12@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD