HypothermiaObsIPHNCT01054209
Electric Warming Mattress to Prevent IPH During LSCS
A study testing Warming with warming mattress in people with Hypothermia and Anesthesia, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will demonstrate whether an electric warming mattress can reduce the number of patients who get cold and shiver after elective cesarean section. Peri-operative hypothermia (body temperature below 36 ºC) is a cause of post-operative complications and patient discomfort. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Hypothermia, Anesthesia, Obstetric Anesthesia Problems
- What is being tested?
- Warming with warming mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Aug 2011
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing elective (planned) caesarean section under spinal or combined spinal and epidural (CSE) anaesthesia will be eligible.
Who cannot join
- Exclusion criteria will be those who refuse, who are unable to fully understand the trial or are under 16 years of age when presenting for their Caesarean section.
- Those that are unable to understand for language issues are excluded with regret due to the difficulties of obtaining interpreters at the time of caesarean section, in recovery and once at home for the telephone interview. Waiting for additional interpretation may delay the clinical management of the patient and also the patient may not be able to convey questions or concerns about the study through mail, email or telephone prior to attending.
- Patients under 16 years of age will be excluded from the trial for reasons of consent. Although a patient less than 16 years of age may have Gillick competence and therefore have the capacity to consent to take part in this trial, as a minor their parents may have concerns leading them to refuse trial entry. Child birth in minors can be very stressful for the patient, family and clinical team and we are keen not to add to this for the purposes of a study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN25BE
About this study
Official title: A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section
This study will demonstrate whether an electric warming mattress can reduce the number of patients who get cold and shiver after elective cesarean section.
Peri-operative hypothermia (body temperature below 36 ºC) is a cause of post-operative complications and patient discomfort. Immediately post-operatively such discomfort is due to increased pain and shivering. Patients say that their time in the recovery ward is very stressful and this is prolonged if they become cold (hypothermic)or shiver. Subsequently, patients can suffer with increased risk of infections and delayed discharge from hospital.
Read more
For patients (and their babies) having Cesarean sections it is important to start breast feeding as soon as possible, but being cold may delay this.
For some types of surgery measures are put in place to stop patients becoming cold and thereby reduce the number of problems. However this is not the case with patients undergoing Cesarean sections because the special blankets through which hot air is blown to keep them warm are inappropriate for mothers giving birth by Cesarean section as it would make it difficult for a mother to have good skin-to-skin contact with her new baby immediately after delivery - an important part in the bonding process.
A solution is to use a new warming mattress. This has been shown to be safe and effective with some types of surgery, but has not been tested in Cesarean sections.
In the investigators study,the investigators will warm a group of patients undergoing planned Cesarean section and compare them to an unwarmed group to see if there is any difference primarily in post-operative temperature. Secondarily, the investigators will also look for differences in total blood loss, incidence of blood transfusion, wound infection, shivering, the immediate health of the baby, time taken to become fit for discharge from recovery, length of hospital stay and time to breast-feeding.
Read the detailed description
This project will be a randomised controlled trial comparing a warming mattress with current standard of care (no warming).
Prospective participants will be invited by letter and provided with a information booklet explaining the study and their rights. Informed consent will be taken in writing.
Patients will be randomised using a protocol created by the Trusts Clinical Investigations Research Unit who will use an Internet based randomisation system.
The researcher will not be blinded as it is not logistically feasible. The statistician analysing the results will be blinded to which group receives warming.
Study data will be collected manually on a standardised data collection sheet.
All enrolled patients will have their temperatures measured at specified times and will be observed for shivering. Data collection required to measure the primary outcomes will be complete by time of discharge from the recovery room. Data collection for secondary outcomes will be prospective and retrospective and will occur from time of anaesthesia through to one month after the procedure.
All patients will receive routine post-operative care.
To ensure any late complications are not missed we will interview the patients by phone one month after the date of their procedure.
- Conditions
- Hypothermia, Anesthesia, Obstetric Anesthesia Problems
- Being tested
- Warming with warming mattress
- Keywords
- Inadvertent Peri-operative Hypothermia, Shivering, Caesarean Section, Elective, Warming Mattress, Regional Anaesthesia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warming with warming mattressDevice
Also called Inditherm Alpha systems, OTM1: 1900mm x 585mm
Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.
Inditherm Alpha systems, OTM1: 1900mm x 585mm
| Study group | Role | What they receive |
|---|---|---|
| A: standard care, no warming | No intervention | Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician |
| B: electric warming mattress | Active comparator | Warming with warming mattress Receives: Device: Warming with warming mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce Post-operative Hypothermia (Defined as Body Temperature of Less Than 36.0ºC) in Patients Undergoing Planned Caesarean Section.
IPH (body temperature of less than 36.0ºC)
Measured: On admission to recovery room - time variable, same day as procedure
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce the Incidence of Shivering in Patients Undergoing Planned Caesarean Section.
Whether an electric warming mattress can reduce the incidence of shivering in patients undergoing planned Caesarean section. Shivering will be described according to severity on a scale of 1-4 where 1 is no shivering and 4 is uncontrolled shivering
Measured: From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure
Secondary outcomes (8)
Differences in Total Blood Loss
Measured: At the end of the Caesarean section - time variable
Differences in Incidence of Blood Transfusion
Measured: From start of Caesarean section to discharge from hospital - times variable
Differences in Wound Infection Rates
Measured: From immediately post-operative till 1 month post procedure
Differences in Shivering (Severity and the Need for Treatment)
Measured: On admission to recovery room - time variable, same day as procedure
Differences in Immediate Health of Baby
Measured: At time of baby's birth - same day as Caesarean section
Differences in Time Taken for Mother to Become Fit for Discharge From Recovery
Measured: Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure
Differences in Length of Hospital Stay
Measured: Worked out reterospectively post-discharge from hospital patient notes
Differences in Time to Breast-feeding (if Mother Chooses to Breast Feed)
Measured: From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionAug 2011
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 HypothermiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust
- Investigators
- Christopher M Harper, MBBS, FRCA, Study chair, BSUH NHS Trust, UKAbhijoy Chakladar, MRCP, FRCA, Principal investigator, BSUH NHS Trust, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054209
- Sponsor's protocol ID
- 09/165/HAR
- Acronym
- ObsIPH
- Status last verified
- Jul 2020
- First submitted
- 20 Jan 2010
- Last updated
- 28 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT01054209
- Acronym / sponsor ID
- ObsIPH / 09/165/HAR
- Conditions
- Hypothermia, Anesthesia, Obstetric Anesthesia Problems
- Keywords
- Inadvertent Peri-operative Hypothermia, Shivering, Caesarean Section, Elective, Warming Mattress, Regional Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will demonstrate whether an electric warming mattress can reduce the number of patients who get cold and shiver after elective cesarean section.
Peri-operative hypothermia (body temperature below 36 ºC) is a cause of post-operative complications and patient discomfort. Immediately post-operatively such discomfort is due to increased pain and shivering. Patients say that their time in the recovery ward is very stressful and this is prolonged if they become cold (hypothermic)or shiver. Subsequently, patients can suffer with increased risk of infections and delayed discharge from hospital.
For patients (and their babies) having Cesarean sections it is important to start breast feeding as soon as possible, but being cold may delay this.
For some types of surgery measures are put in place to stop patients becoming cold and thereby reduce the number of problems. However this is not the case with patients undergoing Cesarean sections because the special blankets through which hot air is blown to keep them warm are inappropriate for mothers giving birth by Cesarean section as it would make it difficult for a mother to have good skin-to-skin contact with her new baby immediately after delivery - an important part in the bonding process.
A solution is to use a new warming mattress. This has been shown to be safe and effective with some types of surgery, but has not been tested in Cesarean sections.
In the investigators study,the investigators will warm a group of patients undergoing planned Cesarean section and compare them to an unwarmed group to see if there is any difference primarily in post-operative temperature. Secondarily, the investigators will also look for differences in total blood loss, incidence of blood transfusion, wound infection, shivering, the immediate health of the baby, time taken to become fit for discharge from recovery, length of hospital stay and time to breast-feeding.
Detailed description
This project will be a randomised controlled trial comparing a warming mattress with current standard of care (no warming).
Prospective participants will be invited by letter and provided with a information booklet explaining the study and their rights. Informed consent will be taken in writing.
Patients will be randomised using a protocol created by the Trusts Clinical Investigations Research Unit who will use an Internet based randomisation system.
The researcher will not be blinded as it is not logistically feasible. The statistician analysing the results will be blinded to which group receives warming.
Study data will be collected manually on a standardised data collection sheet.
All enrolled patients will have their temperatures measured at specified times and will be observed for shivering. Data collection required to measure the primary outcomes will be complete by time of discharge from the recovery room. Data collection for secondary outcomes will be prospective and retrospective and will occur from time of anaesthesia through to one month after the procedure.
All patients will receive routine post-operative care.
To ensure any late complications are not missed we will interview the patients by phone one month after the date of their procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: standard care, no warming | No intervention | –Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician |
| B: electric warming mattress | Active comparator | Device: Warming with warming mattressWarming with warming mattress |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing elective (planned) caesarean section under spinal or combined spinal and epidural (CSE) anaesthesia will be eligible.
Key exclusion criteria (3 listed)
- Exclusion criteria will be those who refuse, who are unable to fully understand the trial or are under 16 years of age when presenting for their Caesarean section.
- Those that are unable to understand for language issues are excluded with regret due to the difficulties of obtaining interpreters at the time of caesarean section, in recovery and once at home for the telephone interview. Waiting for additional interpretation may delay the clinical management of the patient and also the patient may not be able to convey questions or concerns about the study through mail, email or telephone prior to attending.
- Patients under 16 years of age will be excluded from the trial for reasons of consent. Although a patient less than 16 years of age may have Gillick competence and therefore have the capacity to consent to take part in this trial, as a minor their parents may have concerns leading them to refuse trial entry. Child birth in minors can be very stressful for the patient, family and clinical team and we are keen not to add to this for the purposes of a study.
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 |
|---|---|---|
| Warming with warming mattressAlso: Inditherm Alpha systems, OTM1: 1900mm x 585mmReusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively. Inditherm Alpha systems, OTM1: 1900mm x 585mm | Device | B: electric warming mattress |
Primary outcome
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce Post-operative Hypothermia (Defined as Body Temperature of Less Than 36.0ºC) in Patients Undergoing Planned Caesarean Section.
Time frame: On admission to recovery room - time variable, same day as procedure
IPH (body temperature of less than 36.0ºC)
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce the Incidence of Shivering in Patients Undergoing Planned Caesarean Section.
Time frame: From start of anaesthesia till discharge from the recovery room - time variable, same day as procedure
Whether an electric warming mattress can reduce the incidence of shivering in patients undergoing planned Caesarean section. Shivering will be described according to severity on a scale of 1-4 where 1 is no shivering and 4 is uncontrolled shivering
8 secondary outcomes
Differences in Total Blood Loss
Time frame: At the end of the Caesarean section - time variable
Differences in Incidence of Blood Transfusion
Time frame: From start of Caesarean section to discharge from hospital - times variable
Differences in Wound Infection Rates
Time frame: From immediately post-operative till 1 month post procedure
Differences in Shivering (Severity and the Need for Treatment)
Time frame: On admission to recovery room - time variable, same day as procedure
Differences in Immediate Health of Baby
Time frame: At time of baby's birth - same day as Caesarean section
Differences in Time Taken for Mother to Become Fit for Discharge From Recovery
Time frame: Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure
Differences in Length of Hospital Stay
Time frame: Worked out reterospectively post-discharge from hospital patient notes
Differences in Time to Breast-feeding (if Mother Chooses to Breast Feed)
Time frame: From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypothermia
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Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
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Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Christopher M Harper, MBBS, FRCA study chair
BSUH NHS Trust, UK
Abhijoy Chakladar, MRCP, FRCA principal investigator
BSUH NHS Trust, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warming with warming mattress in people with Hypothermia and Anesthesia, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jul 2020. 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 Kingdom. 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. 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 5 Nov 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?
This Study Intends to Investigate Whether an Electric Warming Mattress Can Reduce Post-operative Hypothermia (Defined as Body Temperature of Less Than 36.0ºC) in Patients Undergoing Planned Caesarean Section. (time frame: On admission to recovery room - time variable, same day as procedure). The study lists 2 primary outcomes in all. 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 28 Jul 2020.