Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112317
• Other study ID #: REK Vest (2016/2193)
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Hypothermia
• Infection
• Surgical Site Infection
• Surgical Wound Infection

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