Perioperative Warming Measures in Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby

Official Title
-----------------
Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery

Conditions
-----------------
Hypothermia; Anesthesia, Hypothermia, Newborn, Hypothermia, Sequela

Intervention / Treatment
-----------------
* Device: Pre op upper body forced air warming (32˚C)
* Device: Pre op lower body forced air warming (32˚C)
* Device: Pre op fluids (45˚C)
* Device: Intra op upper body forced air warming (32˚C)
* Device: Intra op fluids at room temperature
* Device: Intra op upper body forced air warming at (32˚C)
* Device: Intra op upper body forced air warming at (42˚C)
* Device: Intra op lower body forced air warming at (32˚C)
* Device: Intra op lower body forced air warming at (42˚C)
* Device: Intra op fluid (42˚C)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for elective cesarean section under neuraxial anesthesia singleton pregnancy Exclusion Criteria: gestational age of less than 37 week emergency cesarean

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body and lower forced air warming intra-operative at 32 and 42˚C respectively and IV fluids with hotline fluid warmer set at 42˚C | Device: Pre op upper body forced air warming (32˚C)<br>* Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes<br>Device: Pre op lower body forced air warming (32˚C)<br>* lower body forced air warming at ambient (32˚C) for at least 30 minutes<br>Device: Pre op fluids (45˚C)<br>* fluids from warmed cabinet set at 45˚C<br>Device: Intra op upper body forced air warming (32˚C)<br>* Use of upper body forced air warming intra-operative at ambient (32˚C)<br>Device: Intra op upper body forced air warming at (32˚C)<br>* upper body forced air warming intra-operative at ambient (32˚C)<br>Device: Intra op upper body forced air warming at (42˚C)<br>* upper body forced air warming intra-operative at ambient (42˚C)<br>Device: Intra op lower body forced air warming at (32˚C)<br>* Lower body forced air warming intra-operative at ambient (32˚C)<br>Device: Intra op lower body forced air warming at (42˚C)<br>* Lower body forced air warming intra-operative at ambient (42˚C)<br>Device: Intra op fluid (42˚C)<br>* IV fluids with hotline fluid warmer set at 42˚C<br>|
| Active Comparator: Control Group<br>Preop: Use of full body forced air warming pre-operative at ambient (32˚C) for at least 30 minutes and fluids from warmed cabinet set at 45˚C Intraop: Use of upper body forced air warming intra-operative at ambient (32˚C) and IV fluids at room temperature | Device: Pre op upper body forced air warming (32˚C)<br>* Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes<br>Device: Pre op lower body forced air warming (32˚C)<br>* lower body forced air warming at ambient (32˚C) for at least 30 minutes<br>Device: Pre op fluids (45˚C)<br>* fluids from warmed cabinet set at 45˚C<br>Device: Intra op upper body forced air warming (32˚C)<br>* Use of upper body forced air warming intra-operative at ambient (32˚C)<br>Device: Intra op fluids at room temperature<br>* IV fluids at room temperature<br>Device: Intra op upper body forced air warming at (32˚C)<br>* upper body forced air warming intra-operative at ambient (32˚C)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maternal core body temperature |  | preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia) | 
| Number of women with hypothermia | Hypothermia is indicated as core temperature < 36 °C | preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia) | 
| Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score | Five criteria are scored and each one is scored form 0-2 with a total score of 10, a higher score indicating a better outcome. | 10 minutes after birth | 
| Neonate status as determined by Umbilical Artery PH | determined by lab value | 10 minutes after birth | 
| Maternal Coagulopathy | determined by lab value | end of surgery (4 hours after anesthesia) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of shivering (severity) | Degree of shivering is measured from 0(no shivering)-3(total body shivering) | on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia] | 
| Number of patients that need meperidine |  | on arrival to PACU [about 4 hours after anesthesia] | 
| Degree of shivering (severity) | Degree of shivering is measured from 0(no shivering)-3(total body shivering) | after 30 minutes in PACU | 
| Number of patients that need meperidine |  | after 30 minutes in PACU | 
| Degree of shivering (severity) | Degree of shivering is measured from 0(no shivering)-3(total body shivering) | after administration of meperidine, if it applies (about 30 minutes in PACU) | 
| Number of patients that show Maternal thermal comfort | scored form 0-10,a higher number indicating more thermal comfort | end of surgery (4 hours after anesthesia) | 
| Perioperative blood loss |  | end of surgery (4 hours ater anesthesia) | 
| Hospital Length of Stay |  | Time of admission to time of discharge (about 72 hours after surgery) |