Comparison of forced air warming with warm intravenous fluid versus forced air warming alone in preventing hypothermia and shivering in obstetric patients
The objective of this study is to compare methods of forced air warming combined
with warm intravenous fluid administration versus forced air warming alone in preventing
hypothermia and shivering associated with spinal anesthesia for elective caesarian section.
Design
A preventive, double blinded, randomized controlled clinical trial with a parallel group design of 390 patients, enrolled between January 2023 and July 2023 and a single center study.
Settings and conduct
Core temperature in both groups was recorded using a standard Braun Infrared Thermoscan5 thermometer (IRT 6500) by a resident anesthetist in the operating room unaware of the study protocol being double blind.
Participants/Inclusion and exclusion criteria
included all ASA-I and II female patients presenting for elective caesarian with a gestational age of 37 or more weeks under spinal anesthesia.
Excluded patients with pre-maturity, caesarian converted to general anesthesia following spinal administration, patients with fever, cardiac or respiratory disease, patients with PIH (pregnancy induced hypertension) or gestational diabetes mellites and patients unwilling to be included in the study.
Intervention groups
The patients were randomized into Group FWI (forced warming with warm IV fluid) and FWA (forced warming alone).
Main outcome variables
Core body temperature measured in degrees Celsius between Group FWI and Group FWA was 37.34±0.17 degrees Celsius versus 37.34±0.16 degrees Celsius measured pre-spinal administration (p=0.922). It was 36.85±0.09 degrees Celsius versus 36.12±0.10 degrees Celsius 30 minutes after spinal during the procedure between both groups (p<0.001) and was36.84±0.09 degrees Celsius versus 36.11±0.10 degrees Celsius measured 60 minutes in the procedure between both groups (p<0.001)
General information
Reason for update
Acronym
None
IRCT registration information
IRCT registration number:IRCT20231022059809N1
Registration date:2024-03-12, 1402/12/22
Registration timing:retrospective
Last update:2024-03-12, 1402/12/22
Update count:0
Registration date
2024-03-12, 1402/12/22
Registrant information
Name
Shujaat Hussain
Name of organization / entity
Combined military hospital Rawapindi
Country
Pakistan
Phone
+92 337 9236235
Email address
shujaat169@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
2023-05-22, 1402/03/01
Actual recruitment end date
2023-11-22, 1402/09/01
Trial completion date
2023-11-22, 1402/09/01
Scientific title
Comparison of forced air warming with warm intravenous fluid versus forced air warming alone in preventing hypothermia and shivering in obstetric patients
Public title
Comparison of forced air warming with warm intravenous fluid versus forced air warming alone in preventing hypothermia and shivering in obstetric patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Included all ASA-I and II Patients
Female patients presenting for elective caesarian with a gestational age of 37 or more weeks under spinal anesthesia.
Exclusion criteria:
Patients with pre-mature gestational age
Caesarian converted to general anesthesia following spinal administration
Patients with fever
Cardiac or Respiratory disease
Patients with PIH (pregnancy induced hypertension) or gestational diabetes mellites
Patients unwilling to be included in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
369
Actual sample size reached:
390
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization was non-probability consecutive via lottery method and patients were randomized into Group FWI (forced warming with warm IV fluid) and FWA (forced warming alone).
Blinding (investigator's opinion)
Double blinded
Blinding description
Core temperature in both groups was recorded using a standard Braun Infrared Thermoscan5 thermometer (IRT 6500) by a resident anesthetist in the operating room unaware of the study protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee Of Combined Military Hospital Rawalpindi
Street address
Saddar Rawalpindi
City
Rawalpindi
Postal code
00666
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
492
Health conditions studied
1
Description of health condition studied
Prevention of hypothermia and shivering associated with spinal anesthesia for elective caesarian section.
ICD-10 code
T88.51
ICD-10 code description
Hypothermia following anesthesia
Primary outcomes
1
Description
Core body temperature in both groups before procedure, per-operatively and post-operatively
Timepoint
Core body temperature in both groups’ pre-spinal, 30 and 60 minutes into the procedure and then at 30- and 60-minute intervals in the PACU post-procedure.
Method of measurement
Core temperature in both groups was recorded using a standard Braun Infrared Thermoscan5 thermometer (IRT 6500) by a resident anesthetist in the operating room unaware of the study protocol.
Secondary outcomes
1
Description
Incidence of Shivering due to hypothermia Per-operative and post-operatively in recovery room
Timepoint
Shivering in both groups’ 30 and 60 minutes into the procedure after spinal and then at 30- and 60-minute intervals in the PACU post-procedure.
Method of measurement
Clinical and visual assessment of Shivering alongwith measurement of core body temperature by using standard Braun Infrared Thermoscan5 thermometer (IRT 6500)
Intervention groups
1
Description
Intervention group: forced air warming with warm intravenous fluid in obstetric patients during Surgical procedures after Spinal Anaesthesia to prevent hypothermia
Category
Prevention
2
Description
Control group: forced air warming alone in obstetric patients during Surgical procedures after Spinal Anaesthesia to prevent hypothermia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Rawalpindi
Full name of responsible person
Saddam Hussain
Street address
Saddar Rawapindi
City
Rawapindi
Postal code
00666
Phone
+92 343 4704199
Email
Shujaat169@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Syed Aqib
Street address
Saddar Rawapindi
City
Rawapindi
Postal code
00666
Phone
+92 343 4704199
Email
aqibalishahsyed@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Rawalpindi
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
Combined Military Hospital Rawalpindi
Full name of responsible person
Shujaat Hussain
Position
Postgraduate Resident
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Saddar Rawapindi
City
Rawapindi
Province
Punjab
Postal code
00666
Phone
+92 343 4704199
Email
Shujaat169@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Rawapindi
Full name of responsible person
Saddam Hussain
Position
Resident trainee
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Saddar Rawapindi
City
Rawapindi
Province
Punjab
Postal code
00666
Phone
0923434704199
Email
Shujaat169@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi
Full name of responsible person
Saddam Hussain
Position
Resident trainee
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Saddar Rawapindi
City
Rawapindi
Province
Punjab
Postal code
00666
Phone
0923434704199
Email
Shujaat169@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