Trial Outcomes & Findings for Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery (NCT NCT02837913)
NCT ID: NCT02837913
Last Updated: 2019-09-18
Results Overview
Temperature at time of post anesthesia care unit admission
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 3.1 • n=10 Participants
|
33.2 years
STANDARD_DEVIATION 5.6 • n=9 Participants
|
34.6 years
STANDARD_DEVIATION 4.5 • n=19 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
19 participants
n=19 Participants
|
|
BMI
|
27.1 kg/m2
STANDARD_DEVIATION 4.3 • n=10 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 7.4 • n=9 Participants
|
29.2 kg/m2
STANDARD_DEVIATION 6.2 • n=19 Participants
|
PRIMARY outcome
Timeframe: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care UnitTemperature at time of post anesthesia care unit admission
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Temperature
Post Anesthesia Care Unit Admission
|
96.5 Degrees Fahrenheit
Standard Deviation 0.8
|
97.1 Degrees Fahrenheit
Standard Deviation 0.8
|
|
Temperature
15 minutes after admission
|
96.0 Degrees Fahrenheit
Standard Deviation 0.6
|
96.1 Degrees Fahrenheit
Standard Deviation 1.0
|
|
Temperature
30 minutes after admission
|
96.7 Degrees Fahrenheit
Standard Deviation 0.8
|
97.5 Degrees Fahrenheit
Standard Deviation 0.7
|
|
Temperature
45 minutes after admission
|
96.9 Degrees Fahrenheit
Standard Deviation 0.6
|
97.1 Degrees Fahrenheit
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care UnitShivering at time of post anesthesia care unit admission
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Number of Participants With Shivering
Arrival in post anesthesia care unit
|
2 Participants
|
1 Participants
|
|
Number of Participants With Shivering
15 minutes after admission
|
2 Participants
|
0 Participants
|
|
Number of Participants With Shivering
30 minutes after admission
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shivering
45 minutes after admission
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervalsPopulation: healthy women undergoing cesarean
Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Vitals: Heart Rate
Preoperative heart rate
|
80.4 beats per minutes
Standard Deviation 10.3
|
77.1 beats per minutes
Standard Deviation 11.9
|
|
Vitals: Heart Rate
PostAnesthesia heart rate
|
84.6 beats per minutes
Standard Deviation 12.8
|
79.8 beats per minutes
Standard Deviation 16.7
|
|
Vitals: Heart Rate
Delivery heart rate
|
87.6 beats per minutes
Standard Deviation 13.8
|
80 beats per minutes
Standard Deviation 13.2
|
|
Vitals: Heart Rate
PostAnesthesiaRecoveryUnit Heart Rate Arrival
|
89.4 beats per minutes
Standard Deviation 10.2
|
77.7 beats per minutes
Standard Deviation 10.9
|
|
Vitals: Heart Rate
PostAnesthesiaRecoveryUnit Heart Rate 15 minutes
|
81.25 beats per minutes
Standard Deviation 17.2
|
62.5 beats per minutes
Standard Deviation 13.4
|
|
Vitals: Heart Rate
PostAnesthesiaRecoveryUnit Heart Rate 30 minutes
|
81.5 beats per minutes
Standard Deviation 16.8
|
53 beats per minutes
Standard Deviation 0
|
|
Vitals: Heart Rate
PostAnesthesiaRecoveryUnit Heart Rate 45 minutes
|
93 beats per minutes
Standard Deviation 0
|
53 beats per minutes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Documented at the end of 2 hour surgical procedurePopulation: healthy pregnant women undergoing cesarean
Estimated blood loss with and without warming
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Blood Loss
|
630 milliliter
Standard Deviation 143.76
|
711.11 milliliter
Standard Deviation 170.99
|
SECONDARY outcome
Timeframe: time from delivery to first maternal contact during the 2 hour surgical procedurePopulation: healthy women undergoing cesarean
time to neonatal bonding as skin to skin
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Time to Neonatal Bonding
|
32 minutes
Standard Deviation 29
|
13 minutes
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervalsPopulation: health women undergoing cesarean
Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Thermal Comfort Visual Analog Scale
Preoperative thermal comfort
|
50.8 units on a scale
Standard Deviation 3.3
|
48.9 units on a scale
Standard Deviation 4.2
|
|
Thermal Comfort Visual Analog Scale
PostAnesthesia thermal comfort
|
48.5 units on a scale
Standard Deviation 3.4
|
47.8 units on a scale
Standard Deviation 3.6
|
|
Thermal Comfort Visual Analog Scale
Delivery Thermal Comfort
|
49.5 units on a scale
Standard Deviation 1.6
|
46.1 units on a scale
Standard Deviation 4.9
|
|
Thermal Comfort Visual Analog Scale
PostAnesthesiaRecoveryUnit Thermal Comfort Arrival
|
49.5 units on a scale
Standard Deviation 3.7
|
45.6 units on a scale
Standard Deviation 9.2
|
|
Thermal Comfort Visual Analog Scale
PostAnesthesiaRecoveryUnit Thermal Comfort 15 min
|
46.3 units on a scale
Standard Deviation 4.8
|
50 units on a scale
Standard Deviation 0
|
|
Thermal Comfort Visual Analog Scale
PostAnesthesiaRecoveryUnit Thermal Comfort 30 min
|
47.5 units on a scale
Standard Deviation 5
|
50 units on a scale
Standard Deviation 0
|
|
Thermal Comfort Visual Analog Scale
PostAnesthesiaRecoveryUnit Thermal Comfort 45 min
|
50 units on a scale
Standard Deviation 0
|
50 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervalsPopulation: healthy women undergoing cesarean
Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Vitals: Oxygen Saturation
Preoperative oxygen saturation
|
99.8 oxygen saturation, %
Standard Deviation 0.4
|
99.7 oxygen saturation, %
Standard Deviation 1
|
|
Vitals: Oxygen Saturation
postAnesthesia oxygen saturation
|
98.8 oxygen saturation, %
Standard Deviation 2.8
|
99.9 oxygen saturation, %
Standard Deviation 0.3
|
|
Vitals: Oxygen Saturation
Delivery oxygen saturation
|
98.3 oxygen saturation, %
Standard Deviation 1.3
|
99.1 oxygen saturation, %
Standard Deviation 1.1
|
|
Vitals: Oxygen Saturation
PostAnesthesiaRecoveryUnit OxygenSaturationArrival
|
98.4 oxygen saturation, %
Standard Deviation 1.6
|
98.7 oxygen saturation, %
Standard Deviation 1.4
|
|
Vitals: Oxygen Saturation
PostAnesthesiaRecoveryUnit OxygenSaturation15minut
|
99.8 oxygen saturation, %
Standard Deviation 0.5
|
99.5 oxygen saturation, %
Standard Deviation 0.7
|
|
Vitals: Oxygen Saturation
PostAnesthesiaRecoveryUnit OxygenSaturation30minut
|
98.8 oxygen saturation, %
Standard Deviation 1.3
|
99 oxygen saturation, %
Standard Deviation 0
|
|
Vitals: Oxygen Saturation
PostAnesthesiaRecoveryUnit OxygenSaturation45minut
|
99 oxygen saturation, %
Standard Deviation 0
|
99 oxygen saturation, %
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervalsPopulation: healthy women undergoing cesarean
Vitals: blood pressure as mean arterial pressure
Outcome measures
| Measure |
Underbody Warmer on
n=10 Participants
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
|
Underbody Warmer Off
n=9 Participants
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
|
|---|---|---|
|
Vitals: Blood Pressure
Preoperative Blood Pressure
|
92.9 mmHg
Standard Deviation 11
|
84.2 mmHg
Standard Deviation 6.7
|
|
Vitals: Blood Pressure
PostAnesthesia Blood Pressure
|
93.3 mmHg
Standard Deviation 12.9
|
90.5 mmHg
Standard Deviation 14.4
|
|
Vitals: Blood Pressure
Delivery Blood Pressure
|
84.4 mmHg
Standard Deviation 10.2
|
92.3 mmHg
Standard Deviation 8.9
|
|
Vitals: Blood Pressure
PostAnesthesiaRecoveryUnit BloodPressure Arrival
|
82.3 mmHg
Standard Deviation 15.3
|
77.1 mmHg
Standard Deviation 9.2
|
|
Vitals: Blood Pressure
PostAnesthesiaRecoveryUnit BloodPressure 15minutes
|
84.3 mmHg
Standard Deviation 12.1
|
85 mmHg
Standard Deviation 2.8
|
|
Vitals: Blood Pressure
PostAnesthesiaRecoveryUnit BloodPressure 30minutes
|
85.8 mmHg
Standard Deviation 12.8
|
—
|
Adverse Events
Underbody Warmer on
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Underbody Warmer Off
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place