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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03112317
Other study ID # REK Vest (2016/2193)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2019
Est. completion date December 31, 2019

Study information

Verified date February 2020
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3059
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Prevention 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.

Locations

Country Name City State
Norway Haukeland University Hospital Bergen Hordaland
Norway Haukeland University Hospital Bergen

Sponsors (2)

Lead Sponsor Collaborator
Haukeland University Hospital University College of Southeast Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intra-operative blood loss (mL) in surgical patients Bleeding that occur during the surgical procedure Within the surgical procedure
Secondary 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
Secondary 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
Secondary 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
Secondary Days admitted in hospital Length of stay in hospital Hospital stay up to 13 days on average
Secondary Hours admitted in post operative care unit (PACU) Length of stay in PACU On average up to 14 hours
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