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.
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 1. 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 2. 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 3. 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 4. 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 5. 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 6. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
66
Lower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position
Control: Lower body blanket placed, not attached to warm air blower
Tel Aviv SMO
Tel Aviv, Israel
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.
Time frame: baseline, immediately before spinal anesthesia, 60 minutes following spinal anesthesia and then every 30 minutes for 2 hours (last measurement prior to discharge)
Maternal hypothermia
Maternal hypothermia yes/no defined as core body temperature \<36°C
Time frame: 60 minutes following spinal anesthesia
Shivering
Shivering score - 0 - no shivering 1. \- One or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity 2. \- Visible muscular activity confined to one muscle group 3. \- Visible muscular activity in more than one muscle group 4. \- Gross muscular activity involving the whole body
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 1 and 5 minutes after newborn delivery
Newborn Temperature
Newborn rectal temperature
Time frame: 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
Time frame: Immediately following placenta removal intraoperatively
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