Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

NCT ID: NCT03112317

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3059 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2019-12-31

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.

Conditions

Surgical Site Infection; Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Hypothermia

Patients with mild hypothermia at start of the surgery

Prevention of hypothermia

Intervention Type: 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.

Normothermia

Patients with normal core temperature at start of surgery.

Prevention of hypothermia

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Forced air warming blankets

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College of Southeast Norway

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arvid S Haugen, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, Hordaland, Norway

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Study Documents

Document Type: Study Protocol

Study protocol is available on request to Regional Committees for Medical and Health Research Ethics.

View Document

Other Identifiers

REK Vest (2016/2193)

Identifier Type: -

Identifier Source: org_study_id