Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Surgical Site Infection
• Intervention / Treatment: Other: Prevention of hypothermia

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.

• Study Type: Observational
• Enrollment (Actual): 3059

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consist of patients undergoing abdominal or gynecologic laparatomy or laparoscopy in a tertiary teaching hospital in Norway.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypothermia; Patients with mild hypothermia at start of the surgery	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.; Other Names: Forced air warming blankets
Normothermia; Patients with normal core temperature at start of surgery.	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.; Other Names: Forced air warming blankets

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University College of Southeast Norway
• Investigators: Principal Investigator: Arvid S Haugen, PhD, MSc, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 26, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Prevention; Surgical Site Infection; Bleeding; Hypothermia; Surgical instruments
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Body Temperature Changes; Wound Infection; Infections; Hemorrhage; Surgical Wound Infection; Hypothermia
• Other Study ID Numbers: REK Vest (2016/2193)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.

Study Data/Documents

1. Study Protocol
   Information identifier: REC West (2016-2193)
   Information comments: Study protocol is available on request to Regional Committees for Medical and Health Research Ethics.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No