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Difficulty recruiting study subjects
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Underbody warmer on | Experimental | Underbody warmer will be underneath the patient and turned on. |
|
| Underbody warmer off | Placebo Comparator | Underbody warmer will be underneath the patient but not turned on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitaHeat underbody heating mattress | Device | Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Temperature | Temperature at time of post anesthesia care unit admission | 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Shivering | Shivering at time of post anesthesia care unit admission | 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit |
| Vitals: Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
• will be age >18 years,
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Underbody Warmer Off |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Temperature | Temperature at time of post anesthesia care unit admission | Posted | Mean | Standard Deviation | Degrees Fahrenheit | 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Zakowski | Cedars-Sinai Medical Center | 310-423-5841 | mark.zakowski@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2017 | May 9, 2019 | Prot_SAP_001.pdf |
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Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit
| Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
| Blood Loss | Estimated blood loss with and without warming | Documented at the end of 2 hour surgical procedure |
| Time to Neonatal Bonding | time to neonatal bonding as skin to skin | time from delivery to first maternal contact during the 2 hour surgical procedure |
| 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 | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
| Vitals: Oxygen Saturation | Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
| Vitals: Blood Pressure | Vitals: blood pressure as mean arterial pressure | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
|
|
| Secondary | Number of Participants With Shivering | Shivering at time of post anesthesia care unit admission | Posted | Count of Participants | Participants | 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit |
|
|
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| Secondary | Vitals: Heart Rate | Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit | healthy women undergoing cesarean | Posted | Mean | Standard Deviation | beats per minutes | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
|
|
|
| Secondary | Blood Loss | Estimated blood loss with and without warming | healthy pregnant women undergoing cesarean | Posted | Mean | Standard Deviation | milliliter | Documented at the end of 2 hour surgical procedure |
|
|
|
| Secondary | Time to Neonatal Bonding | time to neonatal bonding as skin to skin | healthy women undergoing cesarean | Posted | Mean | Standard Deviation | minutes | time from delivery to first maternal contact during the 2 hour surgical procedure |
|
|
|
| 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 | health women undergoing cesarean | Posted | Mean | Standard Deviation | units on a scale | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
|
|
|
| Secondary | Vitals: Oxygen Saturation | Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit | healthy women undergoing cesarean | Posted | Mean | Standard Deviation | oxygen saturation, % | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
|
|
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| Secondary | Vitals: Blood Pressure | Vitals: blood pressure as mean arterial pressure | healthy women undergoing cesarean | Posted | Mean | Standard Deviation | mmHg | Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 9 | 0 | 9 | 0 | 9 |
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| 30 minutes after admission |
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| 45 minutes after admission |
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| Delivery heart rate |
|
| PostAnesthesiaRecoveryUnit Heart Rate Arrival |
|
| PostAnesthesiaRecoveryUnit Heart Rate 15 minutes |
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| PostAnesthesiaRecoveryUnit Heart Rate 30 minutes |
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| PostAnesthesiaRecoveryUnit Heart Rate 45 minutes |
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| Delivery Thermal Comfort |
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| PostAnesthesiaRecoveryUnit Thermal Comfort Arrival |
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| PostAnesthesiaRecoveryUnit Thermal Comfort 15 min |
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| PostAnesthesiaRecoveryUnit Thermal Comfort 30 min |
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| PostAnesthesiaRecoveryUnit Thermal Comfort 45 min |
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| Delivery oxygen saturation |
|
| PostAnesthesiaRecoveryUnit OxygenSaturationArrival |
|
| PostAnesthesiaRecoveryUnit OxygenSaturation15minut |
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| PostAnesthesiaRecoveryUnit OxygenSaturation30minut |
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| PostAnesthesiaRecoveryUnit OxygenSaturation45minut |
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| PostAnesthesia Blood Pressure |
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| Delivery Blood Pressure |
|
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| PostAnesthesiaRecoveryUnit BloodPressure Arrival |
|
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| PostAnesthesiaRecoveryUnit BloodPressure 15minutes |
|
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| PostAnesthesiaRecoveryUnit BloodPressure 30minutes |
|
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| PostAnesthesiaRecoveryUnit BloodPressure 45minutes |
|