A Study to Determine the Effectiveness of a Warming Mattress in Preventing Inadvertent Peri-operative Hypothermia and Shivering in Patients Undergoing Elective Cesarean Section (ObsIPH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr C. Mark Harper, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01054209
First received: January 20, 2010
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Hypothermia
Shivering
Anesthesia, Obstetrical
Anesthesia, Regional
Cesarean Section
Device: Warming with warming mattress

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Brighton and Sussex University Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in total blood loss [ Time Frame: At the end of the Caesarean section - time variable ] [ Designated as safety issue: No ]
  • Differences in incidence of blood transfusion [ Time Frame: From start of Caesarean section to discharge from hospital - times variable ] [ Designated as safety issue: No ]
  • Differences in wound infection rates [ Time Frame: From immediately post-operative till 1 month post procedure ] [ Designated as safety issue: No ]
  • Differences in shivering (severity and the need for treatment) [ Time Frame: On admission to recovery room - time variable, same day as procedure ] [ Designated as safety issue: No ]
  • Differences in immediate health of baby [ Time Frame: At time of baby's birth - same day as Caesarean section ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Differences in length of hospital stay [ Time Frame: Worked out reterospectively post-discharge from hospital patient notes ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Control arm. Full standard care. No mattress warming. May receive warmed fluids if standard practise for clinician
Active Comparator: B
Warming mattress activated otherwise same management as Arm A.
Device: 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

Other Name: Inditherm Alpha systems, OTM1: 1900mm x 585mm

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing elective (planned) caesarean section under spinal or combined spinal and epidural (CSE) anaesthesia will be eligible.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054209

Locations
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom, BN25BE
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
Investigators
Study Chair: Christopher M Harper, MBBS, FRCA BSUH NHS Trust, UK
Principal Investigator: Abhijoy Chakladar, BSc, MBBS, MRCP, FRCA BSUH NHS Trust, UK
  More Information

No publications provided

Responsible Party: Dr C. Mark Harper, Consultant Anaesthetist, Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01054209     History of Changes
Other Study ID Numbers: 09/165/HAR
Study First Received: January 20, 2010
Last Updated: December 6, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Brighton and Sussex University Hospitals NHS Trust:
Inadvertent Peri-operative Hypothermia
Shivering
Caesarean Section
Elective
Warming Mattress
Regional Anaesthesia

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014