Determining the effect of abdominal compression on the consequences of cardiopulmonary resuscitation in hospitalized patients
Design
The present study is a interventional study, parallel design, with a sample size of 90 people. Block randomization based on block permutation is used for randomization. To conceal the allocation, block sizes are also randomly selected (4, 6).
Settings and conduct
The study sample is selected by random sampling method from patients with cardiopulmonary arrest admitted to Razi hospital. Study subjects are blind to the intervention due to lack of knowledge about the type of cardiopulmonary resuscitation (due to loss of consciousness).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Written informed consent from the client's family or guardian, age of 18 to 85 years, hospitalized patients with cardiopulmonary arrest.
Exclusion criteria: patients with liver cirrhosis, history of abdominal surgery in the last two weeks, active gastrointestinal bleeding, abdominal ascites.
Intervention groups
In the intervention group, chest compression will be performed 100 times in a minute at a depth of 5 cm and ventilation will be performed using an Ambobag. Also in this group, abdominal compression is performed simultaneously with chest compression with the hands open and integrated and it is applied in the center of the abdomen between the xiphoid process and the umbilicus during the resting phase of the chest compression. In the control group, chest compression will be performed as in the intervention group, but no abdominal compression will be applied.
Main outcome variables
Spontaneous return of blood flow
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001174N14
Registration date:2021-05-28, 1400/03/07
Registration timing:prospective
Last update:2021-05-28, 1400/03/07
Update count:0
Registration date
2021-05-28, 1400/03/07
Registrant information
Name
Atefeh Ghanbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13780509
Email address
at_ghanbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of abdominal compression on consequences of cardiopulmonary resuscitation in hospitalized patients
Public title
The effect of abdominal compression on consequences of cardiopulmonary resuscitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent from the client's family or guardian
Age of 18 to 85 years
Hospitalized patients with cardiopulmonary arrest
Exclusion criteria:
Patients with liver cirrhosis
History of abdominal surgery in the last two weeks
Active gastrointestinal bleeding
Patients with abdominal ascites
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, block randomization based on block permutation will be used. Initially, based on the specified sample size, the samples will be placed inside the blocks and in each block there will be an equal number of control and intervention groups. The site https://www.sealedenvelope.com/, which was set up to randomize clinical trials, will be used to generate a random allocation sequence in each block. To hide the allocation, the block size will be selected randomly (4, 6). In this case, for the present study, which have two groups, blocks with a size of 4 will include 2 participants from the control group and 2 participants from the intervention group. Also, blocks with a size of 6 will include 3 participants from the control group and 3 participants from the intervention group. Sampling will continue based on the assigned sequences in each block to complete the specified sample size. If the patient leaves the study, the relevant code will be assigned to the next sample.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Deputy of Research and Technology of Guilan University of Medical Sciences., In front of 17Sharivar Hospital., Shahid Siadati St., Namjoo Blvd.
City
Rasht
Province
Guilan
Postal code
4146939114
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.GUMS.REC.1399.665
Health conditions studied
1
Description of health condition studied
Cardiac arrest
ICD-10 code
I46
ICD-10 code description
Cardiac arrest
Primary outcomes
1
Description
Spontaneous return of blood flow
Timepoint
After intervention (immediately after onset and half an hour after cardiopulmonary resuscitation).
Method of measurement
Cardiopulmonary monitor
Secondary outcomes
1
Description
Mean arterial pressure
Timepoint
After intervention (immediately after onset and half an hour after cardiopulmonary resuscitation).
Method of measurement
Cardiopulmonary monitor
2
Description
Arterial blood oxygen saturation
Timepoint
After intervention (immediately after onset and half an hour after cardiopulmonary resuscitation).
Method of measurement
Arterial blood gas test
3
Description
Heart rate
Timepoint
After intervention (immediately after onset and half an hour after cardiopulmonary resuscitation).
Method of measurement
Cardiopulmonary monitor
Intervention groups
1
Description
Intervention group: In the intervention group, chest compression will be performed 100 times in a minute at a depth of 5 cm and ventilation will be performed as soon as possible after intubation. Ventilation will be performed using an Ambobag and intravenous epinephrine and other drugs will be injected intravenously if necessary during resuscitation. Cardiopulmonary resuscitation will continue until the spontaneous return of blood flow and its termination will be one of the indications for termination of cardiopulmonary resuscitation. In this study, abdominal compression is performed simultaneously with chest compression with the hands open and integrated and it is applied in the center of the abdomen between the xiphoid process and the umbilicus during the resting phase of the chest compression. According to similar articles, the depth, rhythm and number of abdominal compression are similar to those of a chest compression, and the pressure on the abdomen continues until the next chest compression begins.
Category
Treatment - Other
2
Description
Control group: In this group, chest compression will be performed and ventilation will be performed as soon as possible after intubation. Ventilation will be performed using an Ambobag and intravenous epinephrine and other drugs will be injected intravenously if necessary during resuscitation. Cardiopulmonary resuscitation will continue until blood flow returns spontaneously and its termination will be one of the indications for termination of cardiopulmonary resuscitation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Educational & Remedial Center, Rasht
Full name of responsible person
Atefeh Ghanbari
Street address
Razi Educational & Remedial Center, Entezam St., Rasht
City
Rasht
Province
Guilan
Postal code
1311141937
Phone
+98 13 3332 6065
Email
bazrasi@gums.ac.ir
Web page address
https://www.gums.ac.ir/razi
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology of Guilan University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Deputy of Research and Technology of Guilan University of Medical Sciences., In front of 17Sharivar Hospital., Shahid Siadati St., Namjoo Blvd.