Postoperative HypothermiaNCT02837913
Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
A study testing VitaHeat underbody heating mattress in people with Postoperative Hypothermia, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Hypothermia
- What is being tested?
- VitaHeat underbody heating mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- will be age >18 years,
- singleton pregnancy >37 weeks,
- neuraxial anesthesia,
- healthy afebrile patients.
Who cannot join
- • will be age >18 years,
- singleton pregnancy >37 weeks,
- neuraxial anesthesia,
- healthy afebrile patients.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Hypothermia
- Being tested
- VitaHeat underbody heating mattress
- Keywords
- Perioperative Warming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaHeat underbody heating mattressDevice
Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively
| Study group | Role | What they receive |
|---|---|---|
| Underbody warmer on | Experimental | Underbody warmer will be underneath the patient and turned on. Receives: Device: VitaHeat underbody heating mattress |
| Underbody warmer off | Placebo comparator | Underbody warmer will be underneath the patient but not turned on. Receives: Device: VitaHeat underbody heating mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Temperature at time of post anesthesia care unit admission
Measured: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
Secondary outcomes (7)
Number of Participants With Shivering
Shivering at time of post anesthesia care unit admission
Measured: 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit
Vitals: Heart Rate
Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit
Measured: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Blood Loss
Estimated blood loss with and without warming
Measured: Documented at the end of 2 hour surgical procedure
Time to Neonatal Bonding
time to neonatal bonding as skin to skin
Measured: 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
Measured: 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
Measured: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Vitals: Blood Pressure
Vitals: blood pressure as mean arterial pressure
Measured: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start5 Jun 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Why it stopped: Difficulty recruiting study subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative HypothermiaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Zakowski MD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837913
- Sponsor's protocol ID
- Pro00039382
- Status last verified
- Aug 2019
- First submitted
- 6 Jul 2016
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02837913
- Acronym / sponsor ID
- Pro00039382
- Conditions
- Postoperative Hypothermia
- Keywords
- Perioperative Warming
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting study subjects
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Posted 18 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underbody warmer on | Experimental | Device: VitaHeat underbody heating mattressUnderbody warmer will be underneath the patient and turned on. |
| Underbody warmer off | Placebo comparator | Device: VitaHeat underbody heating mattressUnderbody warmer will be underneath the patient but not turned on. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- will be age >18 years,
- singleton pregnancy >37 weeks,
- neuraxial anesthesia,
- healthy afebrile patients.
Key exclusion criteria (4 listed)
- • will be age >18 years,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaHeat underbody heating mattressUse of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively | Device | Underbody warmer off, Underbody warmer on |
Primary outcome
Temperature
Time frame: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
Temperature at time of post anesthesia care unit admission
7 secondary outcomes
Number of Participants With Shivering
Time frame: 15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit
Vitals: Heart Rate
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Blood Loss
Time frame: Documented at the end of 2 hour surgical procedure
Time to Neonatal Bonding
Time frame: time from delivery to first maternal contact during the 2 hour surgical procedure
Thermal Comfort Visual Analog Scale
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Vitals: Oxygen Saturation
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Vitals: Blood Pressure
Time frame: Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitaHeat underbody heating mattress in people with Postoperative Hypothermia, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.