Study Results
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Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2022-12-13
2023-03-09
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
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.
Study Groups
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Warm air blower
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
Warm air blower
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
Co-loading of 1000 mL liters of IV warmed-fluids started prior to performing spinal anesthesia
Control: Lower body blanket not attached to warm air blower
Control: Lower body blanket placed, not attached to warm air blower
Interventions
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Warm air blower
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 not attached to warm air blower
Control: Lower body blanket placed, not attached to warm air blower
Eligibility Criteria
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Inclusion Criteria
2. Age between 18-50 years old
3. American Society of Anesthesiologists (ASA) physical status 2-3
4. Gestational age greater than 37 completed weeks
5. Singleton pregnancy
6. Elective cesarean delivery.
Exclusion Criteria
2. Contraindication for spinal anesthesia
1. Patient refusal
2. Bleeding diathesis
3. Neuropathy
18 Years
50 Years
FEMALE
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Locations
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Tel Aviv SMO
Tel Aviv, , Israel
Countries
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Other Identifiers
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CTIL - 0562-22-TLV -
Identifier Type: -
Identifier Source: org_study_id
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