Mild Hypothermia Influence on Patient Outcome in Major Abdominal Surgery

NCT03112317 | Completed

• 1 other identifier: REK Vest (2016/2193)
• Study Type: observational
• Target: 3,059
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Site Infection; Bleeding

Keywords

Surgery; Hypothermia; Prevention; Surgical Site Infection; Bleeding; Surgical instruments

Outcome Measures

Primary Outcomes (1)

• Intra-operative blood loss (mL) in surgical patients

  Bleeding that occur during the surgical procedure

  Within the surgical procedure

Secondary Outcomes (5)

• Peri-operative blood loss (registered by ICD-10 codes)

  Within the duration of the surgical procedures, an average of 2.5 hours

• Number of patients with Surgical Site Infections after surgery

  Up to 30 days after discharge from hospital

• Number of patients with Surgical Site Infection

  Up to 30 days after discharge from hospital

• Days admitted in hospital

  Hospital stay up to 13 days on average

• Hours admitted in post operative care unit (PACU)

  On average up to 14 hours

Study Arms (2)

Hypothermia

Patients with mild hypothermia at start of the surgery

Other: Prevention of hypothermia

Normothermia

Patients with normal core temperature at start of surgery.

Other: Prevention of hypothermia

Interventions

Prevention of hypothermia 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.

Also known as: Forced air warming blankets

Hypothermia; Normothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients (men or women) above 18 years, undergoing abdominal or gynecological surgery with laparotomy or laparoscopy.

You may not qualify if:

• Surgical procedures with intentional reduction of core temperature. Patients under the age of 18.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University College of Southeast Norway: collaborator

Study Sites (2)

Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Surgical Wound Infection; Hemorrhage; Hypothermia

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Study Officials

• Arvid S Haugen, PhD, MSc

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 13, 2017
• Study Start: May 30, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

NO (2)