Comparison of the impact of manual versus mechanical ventilation on arterial blood gases, end-tidal carbon dioxide and arterial oxygen saturation of patients under mechanical ventilation during cardiopulmonary resuscitation
Determining the effect of manual ventilation with mechanical ventilation on arterial blood gases, end-expiratory carbon dioxide and arterial blood oxygen saturation of patients under mechanical ventilation during cardiopulmonary resuscitation.
Design
A clinical trial with a control group, with parallel groups, Single blind , randomized, For randomization, permutation block random allocation with size 6 and the site www.sealedenvelop.com will be used; The said site randomly generates 11 blocks of size 6.
Settings and conduct
Methodology: After allocating patients to the control and intervention groups and obtaining informed consent, cardiopulmonary resuscitation will be performed in both groups based on the latest guidelines, and ventilation will be performed using one of the two common methods (mechanical ventilation or manual ventilation).
Place of study: Hospital and Imam Reza Hospital in Mashhad
The intervention group will receive ventilation during cardiopulmonary resuscitation through RESMED mechanical ventilation device with volume controlled ventilation (VCV) mode settings.The control group will receive manual ventilation during cardiopulmonary resuscitation through an ambobag.
Comparison of the impact of manual versus mechanical ventilation on arterial blood gases, end-tidal carbon dioxide and arterial oxygen saturation of patients under mechanical ventilation during cardiopulmonary resuscitation
Public title
Investigating and comparing the effectiveness of manual and mechanical ventilation on blood gases in patients under mechanical ventilation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18
Definitive cardiopulmonary arrest diagnosis (no response, no carotid pulse, no breath)
Patients with neuropathy diseases
Patients with cv-line
Exclusion criteria:
Traumatic cardiac arrest
Irreversible death
Suspected COVID-19
Suspected pneumothorax
Pregnant
ROSC was achieved before intervention
The patient's withdrawal from the research plan at the doctor's discretion
Patients admitted to the hospital under cardiopulmonary resuscitation.
Patients from whom initial arterial blood gas samples cannot be taken 2 minutes immediately after starting CPR.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be selected as available, and the allocation of patients to study groups will be done using random block allocation with a size of 6, for this purpose, the site www.sealedenvelop.com will be used; The said site randomly generates 11 blocks of size 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
The intervention and control group patients are marked with letters a and b and their information will be provided to the data analyst.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of Nursing and Midwifery faculty
Street address
Daneshgah Street, Qureshi Building, Central Organization of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.133
Health conditions studied
1
Description of health condition studied
cardiopulmonary arrest in patients with neuropathy diseases
ICD-10 code
I46.9
ICD-10 code description
Cardiac arrest, cause unspecified
Primary outcomes
1
Description
End-tidal carbon dioxide
Timepoint
During cardiopulmonary resuscitation every 2 minutes
Method of measurement
A Sidestream portable capnography device from Comdek company, model MD-660P, made in Taiwan and manufactured in 2005.
2
Description
Arterial oxygen saturation
Timepoint
During cardiopulmonary resuscitation every 2 minutes
Method of measurement
A SP-20 handheld pulse oximeter made in Germany in 2019
3
Description
Arterial blood gases
Timepoint
2 minutes immediately after starting CPR and 1 minute after achieving ROSC
Method of measurement
ABG device made in America model GEM 2000
Secondary outcomes
1
Description
Perfusion index
Timepoint
Every two minutes during CPR
Method of measurement
With pulseoximeter
Intervention groups
1
Description
Intervention group: The intervention group will receive ventilation during cardiopulmonary resuscitation through RESMED mechanical ventilation device. Ventilation with volume controlled ventilation (VCV) mode settings, tidal volume 6-7 ml/kg ideal body weight (500 ml in men, 400 ml in women if weight is unknown), positive end-expiratory pressure (PEEP) 0 cmH2O, respiratory rate 10 breaths per minute, inspiratory time 1 second, I:E ratio 1:5, oxygen (FiO2) 1.0, maximum inspiratory pressure alarm range (Pimax) 60 cmH2O, and trigger-20 cmH2O will be performed. Monitoring of end-expiratory carbon dioxide and arterial blood oxygen saturation during resuscitation will be done every two minutes; the initial arterial blood sample will be collected 2 minutes immediately after the start of CPR and 1 minute after achieving ROSC.
Category
N/A
2
Description
Control group: Control group: The control group will receive manual ventilation during cardiopulmonary resuscitation through ambobag. Ventilation will be done with an Ambo bag with a reserve bag (Ambo bag, 1.5 liters) connected to an oxygen flow of at least 15 liters per minute. During resuscitation, the person responsible for breathing will be blinded and the research team will monitor the number of breaths and the tidal volume delivered in each breath through a respirometer. Monitoring of end-expiratory carbon dioxide and arterial blood oxygen saturation during resuscitation will be done every two minutes, the initial arterial blood sample will be collected 2 minutes immediately after the start of CPR and 1 minute after achieving ROSC.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Nastaran Lotfi
Street address
Ahmadabad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9183888136
Phone
+98 51 3801 2435
Email
nastaran.lotfi1378@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Nastaran Lotfi
Street address
Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9183888136
Phone
+98 51 3854 3031
Email
nastaran.lotfi1378@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellor, Qurashi Building, next to Hoizeh Cinema, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nastaran Lotfi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.33, Babak 6th, Babak Ave., Ahmadabad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9183888136
Phone
+98 51 3843 0784
Email
nastaran.lotfi1378@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ferdowsi university of Mashhad, Kharazmi Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nastaran Lotfi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.33, Babak 6th, Babak Ave., Ahmadabad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9183888136
Phone
+98 51 3843 0784
Email
nastaran.lotfi1378@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available