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Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

Does Mild Hypothermia Increase Intra-Operative Blood Loss and Surgical Site Infections in Major Abdominal Surgery?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03112317
Enrollment
3059
Registered
2017-04-13
Start date
2019-05-30
Completion date
2019-12-31
Last updated
2020-06-23

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

Conditions

Bleeding, Surgical Site Infection

Keywords

Surgery, Hypothermia, Prevention, Surgical Site Infection, Bleeding, Surgical instruments

Brief summary

This study investigate associations between mild hypothermia (patients' core temperature ≤ 36.0 degrees Celsius) and intra-operative blood loss and surgical site infections (SSI) in patients undergoing major abdominal surgery.

Detailed description

This study evaluates associations between patients' core temperature during surgery and intra-operative blood loss, and to SSI. Additionally, the investigators observe the use of hypothermia prevention measures in operating theaters, use of surgical safety checklists. SSI is registered at discharge from hospital and up to 30 days post-discharge. The goal of the study is to contribute to focus on prevention of even mild hypothermia in surgery. This study is of interest for healthcare personnel as operating room nurses, surgeons, nurse anaesthetists, anaesthesiologists, ward nurses, post anaesthetic care unit nurses, and other healthcare staff involved in the in-hospital surgical pathway.

Interventions

OTHERPrevention of hypothermia

Patients are routinely warmed with forced air warming blankets, regular blankets, pre warmed intravenous fluid. Routines are ensured with use of the WHO Surgical Safety Checklist. The intervention is the use of operating theatre care measures to prevent mild hypothermia in surgical patients.

Sponsors

University College of Southeast Norway
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

* Patients (men or women) above 18 years, undergoing abdominal or gynecological surgery with laparotomy or laparoscopy.

Exclusion criteria

* Surgical procedures with intentional reduction of core temperature. Patients under the age of 18.

Design outcomes

Primary

MeasureTime frameDescription
Intra-operative blood loss (mL) in surgical patientsWithin the surgical procedureBleeding that occur during the surgical procedure

Secondary

MeasureTime frameDescription
Peri-operative blood loss (registered by ICD-10 codes)Within the duration of the surgical procedures, an average of 2.5 hoursBleeding requiring blood transfusion peri-operatively
Number of patients with Surgical Site Infections after surgeryUp to 30 days after discharge from hospitalPost-operative surgical site infections present before discharge from hospital
Number of patients with Surgical Site InfectionUp to 30 days after discharge from hospitalPost-operative surgical site infection present after discharge from hospital
Days admitted in hospitalHospital stay up to 13 days on averageLength of stay in hospital
Hours admitted in post operative care unit (PACU)On average up to 14 hoursLength of stay in PACU

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026