Are the operating rooms with laminar airflow systems a risk for inadvertent perioperative hypothermia during ureterorenoscopic lithotripsy under spinal anesthesia? A prospective randomized clinical trial.
The aim of our study is to compare that the change of temperature of patients who applied ureterorenoscopic lithotripsy under spinal anesthesia in operating rooms with laminar (LAS-OR) and conventional airflow system (CAS-OR).
Design
Prospective, parallel group and randomized trial
Settings and conduct
A total of 100 volunteers, including Group LAS (n = 50) and Group CAS (n = 50), are planned to be included in the study. The groups of patients will be determined by the random number generation program of the Microsoft Office Exel program (with 100 blocks). The patients will be taken to the operating rooms with laminar airflow system (LAS-OR) or the operating rooms with conventional airflow system (CAS-OR), according to randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria of study: the patients who are ASA (American Society of Anesthesiologists) I-II risk group, between 18-65 age group, body mass index (BMI) between 18.5-29.9.
Exclusion criteria: The patients who treated for hypertension, cardiac arrhythmia, hypothyroid, hyperthyroid and corticoadrenal insufficiency, hypothermia during the preoperative period.
Intervention groups
The patients will be taken to the operating rooms with laminar airflow system (LAS-OR) or the operating rooms with conventional airflow system (CAS-OR), according to randomization.
Main outcome variables
To measure tympanic membrane temperature preoperative and every 15 minutes during ureterorenoscopic lithotripsy.
General information
Reason for update
Acronym
ALARIPHURS
IRCT registration information
IRCT registration number:IRCT20180324039145N5
Registration date:2018-11-02, 1397/08/11
Registration timing:prospective
Last update:2018-11-02, 1397/08/11
Update count:0
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
Recai Dagli
Name of organization / entity
Ahi Evran University Faculty of Medicine
Country
Turkey
Phone
+90 386 213 45 15
Email address
recai.dagli@ahievran.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Are the operating rooms with laminar airflow systems a risk for inadvertent perioperative hypothermia during ureterorenoscopic lithotripsy under spinal anesthesia? A prospective randomized clinical trial.
Public title
Airflow systems in the operating rooms and the heat loss of patients during surgery.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who will be applied ureterorenoscopic surgery under spinal anesthesia
The patients who ASA (American Society of Anesthesiologists) score I-II
The patients who in the 18-65 age group
The patients who with the body mass index (BMI) between 18.5-29.9
Exclusion criteria:
The patients who treated for hypothyroid or hyperthyroid
The patients who treated for corticoadrenal insufficiency
The patients who treated for hypertension or arrhythmia
The patients who treated for hypothermia during preoperative period.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 100 volunteers will be included in this study and divided two groups, laminar airflow systems [Group LAS (n = 50)] and conventional airflow systems [Group CAS (n = 50)].
The random number generation program of the Microsoft Office Exel program will be used to determine the groups of patients (with 100 blocks).
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
Ahi Evran University Ethics Committee for Clinical Investigations
Street address
No.100, Bagbasi St, Kirsehir
City
Kirsehir
Postal code
40100
Approval date
2018-03-27, 1397/01/07
Ethics committee reference number
2018-06/56
Health conditions studied
1
Description of health condition studied
Inadvertent perioperative hypothermia
ICD-10 code
T88.51
ICD-10 code description
Hypothermia following anesthesia
Primary outcomes
1
Description
to detect the change between the preoperative temperature and the temperature measured each fifteen-minutes during the ureterorenoscopic lithotripsy (ΔT).
Timepoint
every fifteen-minutes during the ureterorenoscopic lithotripsy, until the end of the operation.
Method of measurement
The tympanic membrane temperature of patients will be measured with Braun IRT6520
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who will undergo ureterorenoscopic lithotripsy under spinal anesthesia, determined according to randomization, will be taken to the operating rooms with laminar airflow (LAS-OR).
Category
Early detection
2
Description
Control group: Patients who will undergo ureterorenoscopic lithotripsy under spinal anesthesia, determined according to randomization, will be taken to the operating rooms with conventional airflow (CAS-OR).
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine
Full name of responsible person
Recai Dagli
Street address
No. 10, Bagbasi St. , Kirsehir
City
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
recai.dagli@ahievran.edu.tr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine
Full name of responsible person
Recai Dagli
Street address
No.10, Bagbasi St., Kirsehir
City
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
recai.dagli@ahievran.edu.tr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine
Full name of responsible person
Recai Dagli
Position
Ass.Prof.Dr.
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 10, Bagbasi St., Kirsehir
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
recai.dagli@ahievran.edu.tr
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine
Full name of responsible person
Recai Dagli
Position
Ass.Prof.Dr.
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 10, Bagbasi St., Kirsehir
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
recai.dagli@ahievran.edu.tr
Person responsible for updating data
Contact
Name of organization / entity
Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine
Full name of responsible person
Recai Dagli
Position
Ass.Prof.Dr.
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 10, Bagbasi St., Kirsehir
City
Kirsehir
Province
Kirsehir
Postal code
40100
Phone
+90 386 213 45 15
Email
recai.dagli@ahievran.edu.tr
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