Maternal Postop Temperature After Cesarean Delivery

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661136
• Other study ID #: CTIL - 0562-22-TLV -
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: December 2022
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Carolyn Weiniger
• Phone: +972584681838
• Email: carolynw[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Written informed consent

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:

1. Known allergy to local anesthetics

2. Contraindication for spinal anesthesia

1. Patient refusal

2. Bleeding diathesis

3. Neuropathy

Related Conditions & MeSH terms

• Body Temperature Changes
• Cesarean Delivery
• Spinal Anesthesia
• Temperature Change, Body

Intervention

Device:
• 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

Other:
• Control: Lower body blanket not attached to warm air blower
Control: Lower body blanket placed, not attached to warm air blower

Locations

Country	Name	City	State
Israel	Tel Aviv SMO	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal hypothermia	Maternal hypothermia yes/no defined as core body temperature <36°C	60 minutes following spinal anesthesia
Secondary	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)
Secondary	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)
Secondary	Meperidine	Meperidine administration (timing and dose) used to treat shivering	Postoperative - up to two hours during PACU recovery after the procedure
Secondary	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
Secondary	Newborn Temperature	Newborn rectal temperature	Upon newborn's arrival to newborn ward - approximately 30 minutes following delivery
Secondary	Umbilical vein pH	venous blood gases will be obtained for analysis from a double-clamped segment of umbilical cord	Immediately following placenta removal intraoperatively