Clinical trial NCT03112317: Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery
Official title: Does Mild Hypothermia Increase Intra-Operative Blood Loss and Surgical Site Infections in Major Abdominal Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Bleeding
Keywords: Surgery
Hypothermia
Prevention
Surgical Site Infection
Bleeding
Surgical instruments
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University College of Southeast Norway
First posted: 2017-04-13
Enrollment: 3059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consist of patients undergoing abdominal or gynecologic laparatomy or laparoscopy in a tertiary teaching hospital in Norway.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intra-operative blood loss (mL) in surgical patients
timeFrame: Within the surgical procedure
Secondary outcomes:
measure: Peri-operative blood loss (registered by ICD-10 codes)
timeFrame: Within the duration of the surgical procedures, an average of 2.5 hours
measure: Number of patients with Surgical Site Infections after surgery
timeFrame: Up to 30 days after discharge from hospital
measure: Number of patients with Surgical Site Infection
timeFrame: Up to 30 days after discharge from hospital
measure: Days admitted in hospital
timeFrame: Hospital stay up to 13 days on average
measure: Hours admitted in post operative care unit (PACU)
timeFrame: On average up to 14 hours
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Arvid S Haugen, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: