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Preoperative Patient Warming for Prevention of Perioperative Hypothermia in Major Abdominal Surgery

The Effect of Preoperative Patient Warming in the Prevention of Perioperative Hypothermia in Major Abdominal Surgery Under Combined General/Epidural Anaesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01795482
Acronym
THER-6
Enrollment
99
Registered
2013-02-20
Start date
2013-01-31
Completion date
2014-08-31
Last updated
2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Anaesthesia, General Anaesthesia, Perioperative Hypothermia, Preoperative Warming, Prewarming, Temperature Monitoring

Keywords

perioperative hypothermia, prewarming, preoperative warming, general anaesthesia, epidural anaesthesia, temperature measurement

Brief summary

The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

Detailed description

The aim of our study is to evaluate the performance of different durations of active preoperative skin-surface warming (prewarming) to prevent perioperative hypothermia in patients undergoing major abdominal surgery under combined general/epidural anaesthesia. The investigators plan to enroll 99 patients in 3 groups. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.

Interventions

In the intervention groups a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the patients sitting or laying on the operating table for 15 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 3), for 15 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 1, control). All patients will receive forced-air warming after induction of general anaesthesia till end of surgery.

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age over 18 years * planned duration of surgery \> 2 hours * planned for elective major abdominal surgery under combined epidural/general anaesthesia * written informed consent * American society of anesthesiologists status 1-3

Exclusion criteria

* duration of surgery \< 90 min * withdrawal of consent * emergency surgery

Design outcomes

Primary

MeasureTime frameDescription
Incidence of hypothermic patients at arrival at PACU2 hoursAfter the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature \< 36°C)will be measured.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026