Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

Completed

• Conditions: Surgical Site Infection; Bleeding
• Interventions: Other: Prevention of hypothermia

• Registration Number: NCT03112317
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Study Start: 2019-05-30
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3059

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normothermia	Prevention of hypothermia	Patients with normal core temperature at start of surgery.
Hypothermia	Prevention of hypothermia	Patients with mild hypothermia at start of the surgery

Primary Outcome Measures

Name	Time	Method
Intra-operative blood loss (mL) in surgical patients	Within the surgical procedure	Bleeding that occur during the surgical procedure

Secondary Outcome Measures

Name	Time	Method
Hours admitted in post operative care unit (PACU)	On average up to 14 hours	Length of stay in PACU
Number of patients with Surgical Site Infections after surgery	Up to 30 days after discharge from hospital	Post-operative surgical site infections present before discharge from hospital
Days admitted in hospital	Hospital stay up to 13 days on average	Length of stay in hospital
Peri-operative blood loss (registered by ICD-10 codes)	Within the duration of the surgical procedures, an average of 2.5 hours	Bleeding requiring blood transfusion peri-operatively
Number of patients with Surgical Site Infection	Up to 30 days after discharge from hospital	Post-operative surgical site infection present after discharge from hospital

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway