Maternal Postop Temperature After Cesarean Delivery

Study Overview
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Brief Summary
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It is unclear whether routine addition of intra-operative forced-air warming in addition to warmed intravenous fluids during cesarean delivery under spinal anesthesia is beneficial. In this single-center randomized trial, we aim to test the primary null hypothesis that our current protocol of warmed intravenous fluids is similar to a combination of warmed intravenous fluids with intra-operative lower-body forced-air warming to maintain maternal temperature after cesarean delivery under spinal anesthesia. We also aim to assess the rate of maternal shivering during and after the procedure between the two groups, the maternal thermal comfort score, neonatal Apgar scores and umbilical pH levels. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to continue our current protocol of warmed intravenous fluids only during cesarean delivery.

Detailed Description
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Primary aim Investigate whether a combination of intra-operative lower-body forced-air warming and warmed IV fluids is superior to our current standard of warmed IV fluids alone in influencing maternal core temperature following spinal anesthesia for cesarean delivery. Secondary aim To compare mean core temperature on arrival to post-anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone To compare incidence of hypothermia among women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone To compare incidence of shivering following recovery in post anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone To compare thermal comfort levels for women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone To compare use of meperidine in post anesthesia care unit (PACU) to treat postoperative shivering, in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone To compare newborn outcomes (rectal temperature at birth, umbilical vein pH & Apgar scores post-delivery) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone

Official Title
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Maternal Postoperative Temperature After Cesarean Delivery Under Spinal Anesthesia With Warmed Intravenous Fluids: Randomized Controlled Trial With Versus Without Lower Body Forced Air Warming

Conditions
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Temperature Change, Body, Cesarean Delivery, Spinal Anesthesia

Intervention / Treatment
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* Device: Warm air blower
* Other: Control: Lower body blanket not attached to warm air blower


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Age between 18-50 years old American Society of Anesthesiologists (ASA) physical status 2-3 Gestational age greater than 37 completed weeks Singleton pregnancy Elective cesarean delivery. Exclusion Criteria: Known allergy to local anesthetics Contraindication for spinal anesthesia Patient refusal Bleeding diathesis Neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two arms: lower body forced air warming versus none
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm air blower<br>Intra-operative lower-body forced-air warming after spinal anesthesia and co-loading 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia | Device: Warm air blower<br>* Lower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position<br>|
| Active Comparator: Control<br>Co-loading of 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia | Other: Control: Lower body blanket not attached to warm air blower<br>* Control: Lower body blanket placed, not attached to warm air blower<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean core temperature | The primary aim is the mean core temperature on arrival to PACU. The means for the two groups will be compared. | baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hypothermia | Maternal hypothermia yes/no defined as core body temperature <36°C | 60 minutes following spinal anesthesia | 
| Shivering | Shivering score - 0 - no shivering - One or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity - Visible muscular activity confined to one muscle group - Visible muscular activity in more than one muscle group - Gross muscular activity involving the whole body | Postoperative - every 30 minutes for 2 hours (last measurement prior to discharge) | 
| Maternal thermal comfort | Maternal thermal comfort scores (• Thermal comfort scale - a 0 to 10 scale will be used with the descriptors to a single question - How warm or cold are you? o Worst imaginable cold,  thermally neutral,  and  insufferably hot  representing the 0, 5, and 10 of the scale, respectively) will be obtained at baseline, 30 minutes during surgery, and on admission to PACU | baseline, immediately before spinal anesthesia , 60 minutes following spinal anesthesia, and then every 30 minutes for 2 hours (last measurement prior to discharge) | 
| Meperidine | Meperidine administration (timing and dose) used to treat shivering | Postoperative - up to two hours during PACU recovery after the procedure | 
| Apgar | Apgar scores (at 1 and 5 minutes) will be determined by the pediatrician (not involved in the study) | 1 and 5 minutes after newborn delivery | 
| Newborn Temperature | Newborn rectal temperature | Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery | 
| Umbilical vein pH | venous blood gases will be obtained for analysis from a double-clamped segment of umbilical cord | Immediately following placenta removal intraoperatively |