Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Site Infection, Bleeding

Intervention / Treatment
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* Other: Prevention of hypothermia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypothermia<br>Patients with mild hypothermia at start of the surgery | Other: Prevention of hypothermia<br>* 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.<br>* Other names: Forced air warming blankets;|
| Normothermia<br>Patients with normal core temperature at start of surgery. | Other: Prevention of hypothermia<br>* 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.<br>* Other names: Forced air warming blankets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative blood loss (mL) in surgical patients | Bleeding that occur during the surgical procedure | Within the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative blood loss (registered by ICD-10 codes) | Bleeding requiring blood transfusion peri-operatively | Within the duration of the surgical procedures, an average of 2.5 hours | 
| Number of patients with Surgical Site Infections after surgery | Post-operative surgical site infections present before discharge from hospital | Up to 30 days after discharge from hospital | 
| Number of patients with Surgical Site Infection | Post-operative surgical site infection present after discharge from hospital | Up to 30 days after discharge from hospital | 
| Days admitted in hospital | Length of stay in hospital | Hospital stay up to 13 days on average | 
| Hours admitted in post operative care unit (PACU) | Length of stay in PACU | On average up to 14 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Surgical Site Infection, Bleeding, Surgical instruments, Surgery, Hypothermia