Anesthesia, Hypothermia, Obstetric Anesthesia Problems
Conditions
Keywords
Inadvertent Peri-operative Hypothermia, Shivering, Caesarean Section, Elective, Warming Mattress, Regional Anaesthesia
Brief 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. 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.
Interventions
Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively. Inditherm Alpha systems, OTM1: 1900mm x 585mm
Sponsors
Study design
Eligibility
Inclusion criteria
* All patients undergoing elective (planned) caesarean section under spinal or combined spinal and epidural (CSE) anaesthesia will be eligible.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Differences in Wound Infection Rates | From immediately post-operative till 1 month post procedure |
| Differences in Shivering (Severity and the Need for Treatment) | On admission to recovery room - time variable, same day as procedure |
| Differences in Immediate Health of Baby | At time of baby's birth - same day as Caesarean section |
| Differences in Total Blood Loss | At the end of the Caesarean section - time variable |
| Differences in Length of Hospital Stay | Worked out reterospectively post-discharge from hospital patient notes |
| Differences in Time to Breast-feeding (if Mother Chooses to Breast Feed) | From time of admission to recovery room till breast feeding established On admission to recovery room - time variable, hopefully within 24hrs |
| Differences in Time Taken for Mother to Become Fit for Discharge From Recovery | Time mother is ready for discharge from recovery room On admission to recovery room - time variable, same day as procedure |
| Differences in Incidence of Blood Transfusion | From start of Caesarean section to discharge from hospital - times variable |
Countries
United Kingdom
Participant flow
Recruitment details
February 2010- September 2012 Recruitment at preop assessment; consent on admission. Study location: obstetric ward and operating theatres
Pre-assignment details
Entry into study phase on arrival in operating theatre. Final temperature readings to in the PACU
Participants by arm
| Arm | Count |
|---|---|
| A Control: Standard Care Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician | 58 |
| B Intervention: Warming Mattress Warming mattress activated otherwise same management as Arm A.
Warming with warming mattress: Reusable pressure relieving warming mattress. Principle use is to warm patients to prevent hypothermia peri-operatively.
Inditherm Alpha systems, OTM1: 1900mm x 585mm | 58 |
| Total | 116 |
Baseline characteristics
| Characteristic | A Control: Standard Care | B Intervention: Warming Mattress | Total |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 5.8 | 34.3 years STANDARD_DEVIATION 5.9 | 34.0 years STANDARD_DEVIATION 5.8 |
| Incidence IPH | 58 participants | 58 participants | 116 participants |
| Region of Enrollment United Kingdom | 58 participants | 58 participants | 116 participants |
| Sex: Female, Male Female | 58 Participants | 58 Participants | 116 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
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)
Time frame: On admission to recovery room - time variable, same day as procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A: Control Arm: Standard Care | 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. | 58 participants |
| B: Intervention: Warming Mattress | 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. | 58 participants |
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
Time frame: From start of anaesthesia till discharge from the 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 Incidence of Blood Transfusion
Time frame: From start of Caesarean section to discharge from hospital - times variable
Differences in Length of Hospital Stay
Time frame: Worked out reterospectively post-discharge from hospital patient notes
Differences in Shivering (Severity and the Need for Treatment)
Time frame: On admission to recovery room - time variable, same day as procedure
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 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
Differences in Total Blood Loss
Time frame: At the end of the Caesarean section - time variable
Differences in Wound Infection Rates
Time frame: From immediately post-operative till 1 month post procedure