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| Name | Class |
|---|---|
| University College of Southeast Norway | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermia | Patients with mild hypothermia at start of the surgery |
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| Normothermia | Patients with normal core temperature at start of surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention of hypothermia | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative blood loss (mL) in surgical patients | Bleeding that occur during the surgical procedure | Within the surgical procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consist of patients undergoing abdominal or gynecologic laparatomy or laparoscopy in a tertiary teaching hospital in Norway.
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| Name | Affiliation | Role |
|---|---|---|
| Arvid S Haugen, PhD, MSc | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Hordaland | 5021 | Norway | ||
| Haukeland University Hospital |
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| ID | Type | URL | Comment |
|---|---|---|---|
| REC West (2016-2193) | Study Protocol | View IPD |
Anonymous individual data is allowed to share, thought such request must be approved by the REK West. Data will be available from the primary investigator.
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D006470 | Hemorrhage |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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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 |
| Bergen |
| 5021 |
| Norway |
Study protocol is available on request to Regional Committees for Medical and Health Research Ethics. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |