An interventional study of Warm air blower and Control: Lower body blanket not attached to warm air blower in Temperature Change, Body, Cesarean Delivery and Spinal Anesthesia, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Other
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
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 66 is above the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
for spinal anesthesia
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Plan to share: No — no plan
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Mar 2023, 2 months.
Of 44 non-industry interventional studies with no phase under Body Temperature Changes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 2 months is below that.
Counting every sponsor, half of 44 studies reached it within 5 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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