NCT02201095

Brief Summary

During anaesthesia for caesarean section it is common to lose heat and become hypothermic, (\<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid and insulated from cold surfaces. There are also 2 types of machine available to actively warm women;

  1. 1.Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air pockets that have warm air blown into them continuously by a fan.
  2. 2.Conduction Warming Mattress - a thin mattress which covers the operating table and the woman lies on top. The padded mattress has strips of material that heat up when electricity passes through it, similar to a normal electric blanket.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

July 15, 2014

Last Update Submit

October 12, 2016

Conditions

Preoperative Hypothermia

Keywords

caesarean sectionperioperative hypothermiaactive warmingforced air warmingconduction mattress warmingthermal comfortPrevention of

Outcome Measures

Primary Outcomes (1)

  • Mean temperature on arrival in recovery

    The primary outcome of the study is to find whether there is a clinically significant statistical difference between the mean temperatures on arrival in recovery of the control and conduction mattress groups; the control and forced air warming groups; and the conduction mattress and forced air warming groups.

    Temperature will be measured on arrival in recovery.

Secondary Outcomes (1)

  • Peri-operative hypothermia

    Temperature will be measured evry 15 minutes throughout the duration of the procedure and in recovery room. The investigators anticipate that this will be over approximately a 2 hour period.

Other Outcomes (1)

  • Thermal comfort scores

    Thermal comfort will be assessed and scored at 15 minute intervals during surgery and in recovery. We anticipate that this will occur over approximately 2 hours.

Study Arms (3)

Normal care

NO INTERVENTION

Normal care - no active warming

Forced air warming

ACTIVE COMPARATOR

Underbody forced air warming blanket

Device: Forced air warming

Conduction warming mattress

ACTIVE COMPARATOR

Underbody conduction warming mattress

Device: Conduction warming mattress

Interventions

Forced air warmingDEVICE
Also known as: Underbody bairhugger
Forced air warming
Conduction warming mattressDEVICE
Also known as: Inditherm conduction mattress
Conduction warming mattress

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a singleton, uncomplicated pregnancy, presenting for elective caesarean section under spinal anaesthesia, where surgery and anaesthesia are expected to be uncomplicated. Patients scheduled for tubal ligation surgery (sterilisation) as part of the caesarean section may also be included.

You may not qualify if:

  • Age under 18
  • BMI \<19 or \>30
  • Diseases of pregnancy: e.g. pregnancy induced hypertension
  • Grand Multiparity - ie parity of 5 or greater
  • Pre-operative pyrexia (temperature of 37.5 degrees C or greater)
  • Pre-operative hypothermia (temperature 36.0 degrees or cooler)
  • Significant co-existing maternal disease - e.g. congenital heart disease
  • Co-existing maternal disease that could impact on temperature- e.g. hypo/hyperthyroid
  • Coagulation abnormalities or anticipated excessive blood loss including any form of abnormal placentation
  • Surgical procedure expected not to be routine/deviation from normal practice
  • Condition preventing full, informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Study Officials

  • Melanie J Woolnough, Mb ChB

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 25, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

GB(1)