Last reviewed 2019-09-18 · How we verify
Home › Trials › NCT02837913 NCT02837913
Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
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Summary Quick facts Who can join Endpoints Results Related trials Sources
Terminated
NA
Results posted
Last updated 18 September 2019
What this trial tests
NA trial testing VitaHeat underbody heating mattress in Postoperative Hypothermia in 19 participants. Terminated before completion.
Timeline
5 June 2017
Primary endpoint
1 January 2018
Quick facts
Lead sponsor Cedars-Sinai Medical Center Phase NA Status Terminated Study type INTERVENTIONAL Allocation randomized Design parallel Masking double Primary purpose prevention Enrollment 19 Start date 5 June 2017 Primary completion 1 January 2018 Estimated completion 1 January 2018 Sites 1 location across United States
Drugs / interventions tested
VitaHeat underbody heating mattress
Conditions studied
Sponsor
Cedars-Sinai Medical Center
Who can join
Adults 18 to 65, female only, with Postoperative Hypothermia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Temperature
Primary
· 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
Temperature at time of post anesthesia care unit admission
Post Anesthesia Care Unit Admission
Group Value 95% CI Underbody Warmer on 96.5 ± 0.8 Underbody Warmer Off 97.1 ± 0.8
15 minutes after admission
Group Value 95% CI Underbody Warmer on 96.0 ± 0.6 Underbody Warmer Off 96.1 ± 1.0
30 minutes after admission
Group Value 95% CI Underbody Warmer on 96.7 ± 0.8 Underbody Warmer Off 97.5 ± 0.7
45 minutes after admission
Group Value 95% CI Underbody Warmer on 96.9 ± 0.6 Underbody Warmer Off 97.1 ± 0.8
Number of Participants With Shivering
Secondary
· 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
Arrival in post anesthesia care unit
Group Value 95% CI Underbody Warmer on 2 Underbody Warmer Off 1
15 minutes after admission
Group Value 95% CI Underbody Warmer on 2 Underbody Warmer Off 0
30 minutes after admission
Group Value 95% CI Underbody Warmer on 1 Underbody Warmer Off 0
45 minutes after admission
Group Value 95% CI Underbody Warmer on 0 Underbody Warmer Off 0
Vitals: Heart Rate
Secondary
· 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
Preoperative heart rate
Group Value 95% CI Underbody Warmer on 80.4 ± 10.3 Underbody Warmer Off 77.1 ± 11.9
PostAnesthesia heart rate
Group Value 95% CI Underbody Warmer on 84.6 ± 12.8 Underbody Warmer Off 79.8 ± 16.7
Delivery heart rate
Group Value 95% CI Underbody Warmer on 87.6 ± 13.8 Underbody Warmer Off 80 ± 13.2
PostAnesthesiaRecoveryUnit Heart Rate Arrival
Group Value 95% CI Underbody Warmer on 89.4 ± 10.2 Underbody Warmer Off 77.7 ± 10.9
PostAnesthesiaRecoveryUnit Heart Rate 15 minutes
Group Value 95% CI Underbody Warmer on 81.25 ± 17.2 Underbody Warmer Off 62.5 ± 13.4
PostAnesthesiaRecoveryUnit Heart Rate 30 minutes
Group Value 95% CI Underbody Warmer on 81.5 ± 16.8 Underbody Warmer Off 53 ± 0
PostAnesthesiaRecoveryUnit Heart Rate 45 minutes
Group Value 95% CI Underbody Warmer on 93 ± 0 Underbody Warmer Off 53 ± 0
Blood Loss
Secondary
· Documented at the end of 2 hour surgical procedure
Estimated blood loss with and without warming
Group Value 95% CI Underbody Warmer on 630 ± 143.76 Underbody Warmer Off 711.11 ± 170.99
Time to Neonatal Bonding
Secondary
· time from delivery to first maternal contact during the 2 hour surgical procedure
time to neonatal bonding as skin to skin
Group Value 95% CI Underbody Warmer on 32 ± 29 Underbody Warmer Off 13 ± 10.3
Thermal Comfort Visual Analog Scale
Secondary
· 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
Preoperative thermal comfort
Group Value 95% CI Underbody Warmer on 50.8 ± 3.3 Underbody Warmer Off 48.9 ± 4.2
PostAnesthesia thermal comfort
Group Value 95% CI Underbody Warmer on 48.5 ± 3.4 Underbody Warmer Off 47.8 ± 3.6
Delivery Thermal Comfort
Group Value 95% CI Underbody Warmer on 49.5 ± 1.6 Underbody Warmer Off 46.1 ± 4.9
PostAnesthesiaRecoveryUnit Thermal Comfort Arrival
Group Value 95% CI Underbody Warmer on 49.5 ± 3.7 Underbody Warmer Off 45.6 ± 9.2
PostAnesthesiaRecoveryUnit Thermal Comfort 15 min
Group Value 95% CI Underbody Warmer on 46.3 ± 4.8 Underbody Warmer Off 50 ± 0
PostAnesthesiaRecoveryUnit Thermal Comfort 30 min
Group Value 95% CI Underbody Warmer on 47.5 ± 5 Underbody Warmer Off 50 ± 0
PostAnesthesiaRecoveryUnit Thermal Comfort 45 min
Group Value 95% CI Underbody Warmer on 50 ± 0 Underbody Warmer Off 50 ± 0
Vitals: Oxygen Saturation
Secondary
· 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
Preoperative oxygen saturation
Group Value 95% CI Underbody Warmer on 99.8 ± 0.4 Underbody Warmer Off 99.7 ± 1
postAnesthesia oxygen saturation
Group Value 95% CI Underbody Warmer on 98.8 ± 2.8 Underbody Warmer Off 99.9 ± 0.3
Delivery oxygen saturation
Group Value 95% CI Underbody Warmer on 98.3 ± 1.3 Underbody Warmer Off 99.1 ± 1.1
PostAnesthesiaRecoveryUnit OxygenSaturationArrival
Group Value 95% CI Underbody Warmer on 98.4 ± 1.6 Underbody Warmer Off 98.7 ± 1.4
PostAnesthesiaRecoveryUnit OxygenSaturation15minut
Group Value 95% CI Underbody Warmer on 99.8 ± 0.5 Underbody Warmer Off 99.5 ± 0.7
PostAnesthesiaRecoveryUnit OxygenSaturation30minut
Group Value 95% CI Underbody Warmer on 98.8 ± 1.3 Underbody Warmer Off 99 ± 0
PostAnesthesiaRecoveryUnit OxygenSaturation45minut
Group Value 95% CI Underbody Warmer on 99 ± 0 Underbody Warmer Off 99 ± 0
Vitals: Blood Pressure
Secondary
· Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Vitals: blood pressure as mean arterial pressure
Preoperative Blood Pressure
Group Value 95% CI Underbody Warmer on 92.9 ± 11 Underbody Warmer Off 84.2 ± 6.7
PostAnesthesia Blood Pressure
Group Value 95% CI Underbody Warmer on 93.3 ± 12.9 Underbody Warmer Off 90.5 ± 14.4
Delivery Blood Pressure
Group Value 95% CI Underbody Warmer on 84.4 ± 10.2 Underbody Warmer Off 92.3 ± 8.9
PostAnesthesiaRecoveryUnit BloodPressure Arrival
Group Value 95% CI Underbody Warmer on 82.3 ± 15.3 Underbody Warmer Off 77.1 ± 9.2
PostAnesthesiaRecoveryUnit BloodPressure 15minutes
Group Value 95% CI Underbody Warmer on 84.3 ± 12.1 Underbody Warmer Off 85 ± 2.8
PostAnesthesiaRecoveryUnit BloodPressure 30minutes
Group Value 95% CI Underbody Warmer on 85.8 ± 12.8
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT02837913 (US National Library of Medicine, public domain)Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by Cedars-Sinai Medical CenterLast refreshed : 18 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02837913.
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