Effects of using Forced Hot Air System on physiological parameters, waking time and arterial blood gases in patients undergoing coronary artery bypass grafting surgery in Bushehr heart hospital in 2019
The effect of using compressed air system on physiological parameters, time of awakening and arterial blood gas in patients undergoing coronary artery bypass graft surgery in Bushehr Heart Hospital
Design
Clinical trial with control group, with parallel groups, randomized controlled block, single blind
Settings and conduct
This study will be carried out at Bushehr Heart Hospital. Eligible male and female cardiac patients undergoing elective coronary artery bypass surgery in 1398 will be included in the study. Patients will then be randomly assigned to one of two groups receiving either warm compressed air or routine care.
ABG and physiologic data (patient ICU admission and patient awakening) data, FOUR Score Assessment results (from patient admission to ICU, patient response to verbal, visual, and auditory stimulation every 15 minutes) Will be collected in a checklist designed by the researcher.
Description of Blindness: For the control group, the compressed air system is used if the patient's perception is the opposite.
Participants/Inclusion and exclusion criteria
Entry requirements:
Being at least 18 years old
Having a tympanic temperature below 36 ° C
EF (ejection fraction) greater than 40%
Exclusion criteria:
Sensory-motor disorder such as patients with Guillain Barre or Myasthenia gravis
Inflammation, pus excretion or discharge into the ear canal or ear injuries Patient restlessness
If drainage exceeds 100 cc / hr in the ICU ward for more than 4 hours
Take high-dose inotropic drugs
Re surgery (Reexploration) to control bleeding
Patients with diagnosis of M.S and A.S (mitral and aortic stenosis)
Severe anemia (hemoglobin less than 8)
Intervention groups
Intervention group:Receiver for hot compressed air heating system (Warm Touch brand (u WT Model COVIDIEN6000))
Main outcome variables
Physiological indicators
Time to wake up after surgery
Arterial Blood Gas Parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190809044488N1
Registration date:2020-01-13, 1398/10/23
Registration timing:registered_while_recruiting
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
Sharif Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3344 5173
Email address
sharif.sharifi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-07, 1398/06/16
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of using Forced Hot Air System on physiological parameters, waking time and arterial blood gases in patients undergoing coronary artery bypass grafting surgery in Bushehr heart hospital in 2019
Public title
Effects of using Forced Hot air system on physiological parameters, waking time and arterial blood gases in patients undergoing coronary artery bypass grafting surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 18 years old
Having a tympanic temperature below 36 ° C
EF (ejection fraction) greater than 40%
Exclusion criteria:
Sensory-motor disorder such as patients with Guillain Barre or Myasthenia gravis
Inflammation, pus excretion or discharge into the ear canal or ear injuries
Patient restlessness
If drainage exceeds 100 cc / hr in the ICU ward for more than 4 hours
Take high-dose inotropic drugs
Resurgery (Reexploration) to control bleeding
Patients with diagnosis of M.S and A.S (mitral and aortic stenosis)
Severe anemia (hemoglobin less than 1)
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
We will use Simple Random Sampling to allocate patients in groups. A colleague who will not perform any clinical measurements on study subjects, will use a coin-flip to randomly assign study subjects to either intervention (hot compressed air system) and control (ordinary blankets) groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the research conditions full blindness is impossible. The study is single-blind (Patients are not aware of being in the intervention or control group).Because patients are not awake at the time of admission to the intensive care unit, it is not possible for them to be aware of either of the control or intervention groups are included.
Patient awakening occurs after at least three hours of admission to the intensive care unit and this coincides with the time of completion of the Intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bushehr University of Medical Sciences
Street address
Bushehr Sabzabad- Bushehr University of Medical Sciences- Pardis site- Next to Salman Farsi Hospital.
City
Bushehr
Province
Boushehr
Postal code
7565184345
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.BPUMS.REC.1398.061
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physiological indicators
Timepoint
The time the patient enters the ICU and the time the patient regains consciousness
Method of measurement
check list
2
Description
Time to wake up after surgery
Timepoint
The patient's response to verbal, visual, and auditory stimulation is monitored every 15 minutes since the patient's arrival in the ICU.
Method of measurement
FOUR Score evaluation method
3
Description
Arterial Blood Gas Parameters
Timepoint
The time the patient enters the ICU and the time the patient regains consciousness
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Receiver for hot compressed air heating system (Warm Touch brand (u WT Model COVIDIEN6000))
Category
Treatment - Devices
2
Description
Using a plain blanket (from a specific brand in two-dimensional (114 by 175 cm) layers covering the armpit to the toe) to warm the patient after surgery
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr Heart Hospital
Full name of responsible person
Soheila Esfandiari, MSc Nursing Student
Street address
Bushehr, Teacher Street
City
Bushehr
Province
Boushehr
Postal code
7513934698
Phone
+98 77 3333 2962
Email
soheylaesfandiari7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Bushehr Sabzabad- Bushehr University of Medical Sciences- Pardis site- Next to Salman Farsi Hospital.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
ghr.khamisi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Sharif Sharifi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bushehr, Sabzabad, Bushehr University of Medical Sciences, Pardis site, Next to Salman Farsi Hospital.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
sharif.sharifi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Sharif Sharifi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bushehr, Sabzabad Ave, Bushehr University of Medical Sciences, Pardis site, Next to Salman Farsi Hospital.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
009833450187
Email
sharif.sharifi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Sharif Sharifi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bushehr, Sabzabad Ave, Bushehr University of Medical Sciences, Pardis site, Next to Salman Farsi Hospital.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
sharif.sharifi@yahoo.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