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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warm air blower | Experimental | 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 |
|
| Control | Active Comparator | Co-loading of 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warm air blower | Device | Lower body blanket with warm air blower set at 44 deg c started after spinal anesthesia when patient placed in supine/left lat position |
|
| 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) |
| 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
|
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Inclusion Criteria:
Exclusion Criteria:
Known allergy to local anesthetics
Contraindication for spinal anesthesia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv SMO | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38614895 | Derived | Haim S, Cohen B, Lustig A, Greenberger C, Aptekman B, Weiniger CF. Lower-body warming and postoperative temperature in cesarean delivery under spinal anesthesia: a randomized controlled trial. Int J Obstet Anesth. 2024 May;58:103990. doi: 10.1016/j.ijoa.2024.103990. Epub 2024 Mar 21. No abstract available. |
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| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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two arms: lower body forced air warming versus none
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Postanesthesia care unit nurses assess primary outcome and will not know the group assignment
Sample size was calculated for the primary outcome of difference between the groups in maternal temperature on arrival to the post-anesthesia care unit. We calculated the a priori sample size, WinPepi, based upon a prior publication that compared Active-Warming versus No-Warming, mean(standard deviation) 35.9(0.5)0 C versus 35.5(0.5), power 90%, 0.05 two-sided significance (Cobb et al). For clinical significance we calculated sample size with a mean difference of 0.50 C, with SD 0.5, power 90%, two sided significance with potential for 10% dropouts, total 66 women, 33 per group, and without dropouts, 22 per group total 44 women.
| Control: Lower body blanket not attached to warm air blower | Other | Control: Lower body blanket placed, not attached to warm air blower |
|
| 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 |