Postoperative Hypothermia
Conditions
Keywords
Perioperative Warming
Brief summary
The primary aim of the current study will be to determine if the use of an underbody heating mattress during cesarean sections will decrease the incidence of postoperative hypothermia, defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia. As part of the primary outcome the difference in the incidence of shivering, its severity, and need for treatment will be investigated. As a secondary goal other maternal perioperative outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to skin' contact. The relationship between maternal hypothermia and newborn outcomes of temperature and APGAR scores will also be evaluated. Active preoperative and intraoperative warming may prevents inadvertent perioperative hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The underbody warming mattress may be a step towards finding a suitable form of warming that is comfortable for awake patients, does not interfere with skin to skin contact and maternal-fetal bonding.
Interventions
DEVICEVitaHeat underbody heating mattress
Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* will be age \>18 years, * singleton pregnancy \>37 weeks, * neuraxial anesthesia, * healthy afebrile patients.
Exclusion criteria
* • will be age \>18 years, * singleton pregnancy \>37 weeks, * neuraxial anesthesia, * healthy afebrile patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature | 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit | Temperature at time of post anesthesia care unit admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitals: Heart Rate | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals | Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit |
| Blood Loss | Documented at the end of 2 hour surgical procedure | Estimated blood loss with and without warming |
| Time to Neonatal Bonding | time from delivery to first maternal contact during the 2 hour surgical procedure | time to neonatal bonding as skin to skin |
| Number of Participants With Shivering | 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit | Shivering at time of post anesthesia care unit admission |
| Vitals: Oxygen Saturation | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals | Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit |
| Vitals: Blood Pressure | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals | Vitals: blood pressure as mean arterial pressure |
| Thermal Comfort Visual Analog Scale | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals | Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Underbody Warmer on Underbody warmer will be underneath the patient and turned on.
VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively | 10 |
| Underbody Warmer Off Underbody warmer will be underneath the patient but not turned on.
VitaHeat underbody heating mattress: Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | Underbody Warmer on | Underbody Warmer Off | Total |
|---|---|---|---|
| Age, Continuous | 35.8 years STANDARD_DEVIATION 3.1 | 33.2 years STANDARD_DEVIATION 5.6 | 34.6 years STANDARD_DEVIATION 4.5 |
| BMI | 27.1 kg/m2 STANDARD_DEVIATION 4.3 | 31.5 kg/m2 STANDARD_DEVIATION 7.4 | 29.2 kg/m2 STANDARD_DEVIATION 6.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 participants | 9 participants | 19 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
Primary
Temperature
Temperature at time of post anesthesia care unit admission
Time frame: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Underbody Warmer on | Temperature | 45 minutes after admission | 96.9 Degrees Fahrenheit | Standard Deviation 0.6 |
| Underbody Warmer on | Temperature | 30 minutes after admission | 96.7 Degrees Fahrenheit | Standard Deviation 0.8 |
| Underbody Warmer on | Temperature | 15 minutes after admission | 96.0 Degrees Fahrenheit | Standard Deviation 0.6 |
| Underbody Warmer on | Temperature | Post Anesthesia Care Unit Admission | 96.5 Degrees Fahrenheit | Standard Deviation 0.8 |
| Underbody Warmer Off | Temperature | 45 minutes after admission | 97.1 Degrees Fahrenheit | Standard Deviation 0.8 |
| Underbody Warmer Off | Temperature | Post Anesthesia Care Unit Admission | 97.1 Degrees Fahrenheit | Standard Deviation 0.8 |
| Underbody Warmer Off | Temperature | 15 minutes after admission | 96.1 Degrees Fahrenheit | Standard Deviation 1 |
| Underbody Warmer Off | Temperature | 30 minutes after admission | 97.5 Degrees Fahrenheit | Standard Deviation 0.7 |
Secondary
Blood Loss
Estimated blood loss with and without warming
Time frame: Documented at the end of 2 hour surgical procedure
Population: healthy pregnant women undergoing cesarean
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Underbody Warmer on | Blood Loss | 630 milliliter | Standard Deviation 143.76 |
| Underbody Warmer Off | Blood Loss | 711.11 milliliter | Standard Deviation 170.99 |
Secondary
Number of Participants With Shivering
Shivering at time of post anesthesia care unit admission
Time frame: 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Underbody Warmer on | Number of Participants With Shivering | Arrival in post anesthesia care unit | 2 Participants |
| Underbody Warmer on | Number of Participants With Shivering | 15 minutes after admission | 2 Participants |
| Underbody Warmer on | Number of Participants With Shivering | 30 minutes after admission | 1 Participants |
| Underbody Warmer on | Number of Participants With Shivering | 45 minutes after admission | 0 Participants |
| Underbody Warmer Off | Number of Participants With Shivering | 45 minutes after admission | 0 Participants |
| Underbody Warmer Off | Number of Participants With Shivering | Arrival in post anesthesia care unit | 1 Participants |
| Underbody Warmer Off | Number of Participants With Shivering | 30 minutes after admission | 0 Participants |
| Underbody Warmer Off | Number of Participants With Shivering | 15 minutes after admission | 0 Participants |
Secondary
Thermal Comfort Visual Analog Scale
Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Population: health women undergoing cesarean
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Underbody Warmer on | Thermal Comfort Visual Analog Scale | Delivery Thermal Comfort | 49.5 units on a scale | Standard Deviation 1.6 |
| Underbody Warmer on | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort 15 min | 46.3 units on a scale | Standard Deviation 4.8 |
| Underbody Warmer on | Thermal Comfort Visual Analog Scale | PostAnesthesia thermal comfort | 48.5 units on a scale | Standard Deviation 3.4 |
| Underbody Warmer on | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort 30 min | 47.5 units on a scale | Standard Deviation 5 |
| Underbody Warmer on | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort Arrival | 49.5 units on a scale | Standard Deviation 3.7 |
| Underbody Warmer on | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort 45 min | 50 units on a scale | Standard Deviation 0 |
| Underbody Warmer on | Thermal Comfort Visual Analog Scale | Preoperative thermal comfort | 50.8 units on a scale | Standard Deviation 3.3 |
| Underbody Warmer Off | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort 45 min | 50 units on a scale | Standard Deviation 0 |
| Underbody Warmer Off | Thermal Comfort Visual Analog Scale | Preoperative thermal comfort | 48.9 units on a scale | Standard Deviation 4.2 |
| Underbody Warmer Off | Thermal Comfort Visual Analog Scale | PostAnesthesia thermal comfort | 47.8 units on a scale | Standard Deviation 3.6 |
| Underbody Warmer Off | Thermal Comfort Visual Analog Scale | Delivery Thermal Comfort | 46.1 units on a scale | Standard Deviation 4.9 |
| Underbody Warmer Off | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort Arrival | 45.6 units on a scale | Standard Deviation 9.2 |
| Underbody Warmer Off | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort 15 min | 50 units on a scale | Standard Deviation 0 |
| Underbody Warmer Off | Thermal Comfort Visual Analog Scale | PostAnesthesiaRecoveryUnit Thermal Comfort 30 min | 50 units on a scale | Standard Deviation 0 |
Secondary
Time to Neonatal Bonding
time to neonatal bonding as skin to skin
Time frame: time from delivery to first maternal contact during the 2 hour surgical procedure
Population: healthy women undergoing cesarean
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Underbody Warmer on | Time to Neonatal Bonding | 32 minutes | Standard Deviation 29 |
| Underbody Warmer Off | Time to Neonatal Bonding | 13 minutes | Standard Deviation 10.3 |
Secondary
Vitals: Blood Pressure
Vitals: blood pressure as mean arterial pressure
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Population: healthy women undergoing cesarean
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Underbody Warmer on | Vitals: Blood Pressure | Preoperative Blood Pressure | 92.9 mmHg | Standard Deviation 11 |
| Underbody Warmer on | Vitals: Blood Pressure | PostAnesthesia Blood Pressure | 93.3 mmHg | Standard Deviation 12.9 |
| Underbody Warmer on | Vitals: Blood Pressure | Delivery Blood Pressure | 84.4 mmHg | Standard Deviation 10.2 |
| Underbody Warmer on | Vitals: Blood Pressure | PostAnesthesiaRecoveryUnit BloodPressure Arrival | 82.3 mmHg | Standard Deviation 15.3 |
| Underbody Warmer on | Vitals: Blood Pressure | PostAnesthesiaRecoveryUnit BloodPressure 15minutes | 84.3 mmHg | Standard Deviation 12.1 |
| Underbody Warmer on | Vitals: Blood Pressure | PostAnesthesiaRecoveryUnit BloodPressure 30minutes | 85.8 mmHg | Standard Deviation 12.8 |
| Underbody Warmer Off | Vitals: Blood Pressure | Preoperative Blood Pressure | 84.2 mmHg | Standard Deviation 6.7 |
| Underbody Warmer Off | Vitals: Blood Pressure | PostAnesthesiaRecoveryUnit BloodPressure 15minutes | 85 mmHg | Standard Deviation 2.8 |
| Underbody Warmer Off | Vitals: Blood Pressure | PostAnesthesia Blood Pressure | 90.5 mmHg | Standard Deviation 14.4 |
| Underbody Warmer Off | Vitals: Blood Pressure | PostAnesthesiaRecoveryUnit BloodPressure Arrival | 77.1 mmHg | Standard Deviation 9.2 |
| Underbody Warmer Off | Vitals: Blood Pressure | Delivery Blood Pressure | 92.3 mmHg | Standard Deviation 8.9 |
Secondary
Vitals: Heart Rate
Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Population: healthy women undergoing cesarean
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Underbody Warmer on | Vitals: Heart Rate | Delivery heart rate | 87.6 beats per minutes | Standard Deviation 13.8 |
| Underbody Warmer on | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate 15 minutes | 81.25 beats per minutes | Standard Deviation 17.2 |
| Underbody Warmer on | Vitals: Heart Rate | PostAnesthesia heart rate | 84.6 beats per minutes | Standard Deviation 12.8 |
| Underbody Warmer on | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate 30 minutes | 81.5 beats per minutes | Standard Deviation 16.8 |
| Underbody Warmer on | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate Arrival | 89.4 beats per minutes | Standard Deviation 10.2 |
| Underbody Warmer on | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate 45 minutes | 93 beats per minutes | Standard Deviation 0 |
| Underbody Warmer on | Vitals: Heart Rate | Preoperative heart rate | 80.4 beats per minutes | Standard Deviation 10.3 |
| Underbody Warmer Off | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate 45 minutes | 53 beats per minutes | Standard Deviation 0 |
| Underbody Warmer Off | Vitals: Heart Rate | Preoperative heart rate | 77.1 beats per minutes | Standard Deviation 11.9 |
| Underbody Warmer Off | Vitals: Heart Rate | PostAnesthesia heart rate | 79.8 beats per minutes | Standard Deviation 16.7 |
| Underbody Warmer Off | Vitals: Heart Rate | Delivery heart rate | 80 beats per minutes | Standard Deviation 13.2 |
| Underbody Warmer Off | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate Arrival | 77.7 beats per minutes | Standard Deviation 10.9 |
| Underbody Warmer Off | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate 15 minutes | 62.5 beats per minutes | Standard Deviation 13.4 |
| Underbody Warmer Off | Vitals: Heart Rate | PostAnesthesiaRecoveryUnit Heart Rate 30 minutes | 53 beats per minutes | Standard Deviation 0 |
Secondary
Vitals: Oxygen Saturation
Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Population: healthy women undergoing cesarean
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Underbody Warmer on | Vitals: Oxygen Saturation | Delivery oxygen saturation | 98.3 oxygen saturation, % | Standard Deviation 1.3 |
| Underbody Warmer on | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturation15minut | 99.8 oxygen saturation, % | Standard Deviation 0.5 |
| Underbody Warmer on | Vitals: Oxygen Saturation | postAnesthesia oxygen saturation | 98.8 oxygen saturation, % | Standard Deviation 2.8 |
| Underbody Warmer on | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturation30minut | 98.8 oxygen saturation, % | Standard Deviation 1.3 |
| Underbody Warmer on | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturationArrival | 98.4 oxygen saturation, % | Standard Deviation 1.6 |
| Underbody Warmer on | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturation45minut | 99 oxygen saturation, % | Standard Deviation 0 |
| Underbody Warmer on | Vitals: Oxygen Saturation | Preoperative oxygen saturation | 99.8 oxygen saturation, % | Standard Deviation 0.4 |
| Underbody Warmer Off | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturation45minut | 99 oxygen saturation, % | Standard Deviation 0 |
| Underbody Warmer Off | Vitals: Oxygen Saturation | Preoperative oxygen saturation | 99.7 oxygen saturation, % | Standard Deviation 1 |
| Underbody Warmer Off | Vitals: Oxygen Saturation | postAnesthesia oxygen saturation | 99.9 oxygen saturation, % | Standard Deviation 0.3 |
| Underbody Warmer Off | Vitals: Oxygen Saturation | Delivery oxygen saturation | 99.1 oxygen saturation, % | Standard Deviation 1.1 |
| Underbody Warmer Off | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturationArrival | 98.7 oxygen saturation, % | Standard Deviation 1.4 |
| Underbody Warmer Off | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturation15minut | 99.5 oxygen saturation, % | Standard Deviation 0.7 |
| Underbody Warmer Off | Vitals: Oxygen Saturation | PostAnesthesiaRecoveryUnit OxygenSaturation30minut | 99 oxygen saturation, % | Standard Deviation 0 |