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NCT Number: NCT03112317

Mild Hypothermia Influence on Patient Outcome 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.

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Key information

Conditions

Surgical Site Infection Bleeding Body Temperature Changes Hemorrhage Hypothermia Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Hordaland, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Forced air warming blankets

Primary outcomes

  1. Intra-operative blood loss (mL) in surgical patients

    Time frame: Within the surgical procedure

    Bleeding that occur during the surgical procedure

Secondary outcomes

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

    Time frame: Within the duration of the surgical procedures, an average of 2.5 hours

    Bleeding requiring blood transfusion peri-operatively

  2. Number of patients with Surgical Site Infections after surgery

    Time frame: Up to 30 days after discharge from hospital

    Post-operative surgical site infections present before discharge from hospital

  3. Number of patients with Surgical Site Infection

    Time frame: Up to 30 days after discharge from hospital

    Post-operative surgical site infection present after discharge from hospital

  4. Days admitted in hospital

    Time frame: Hospital stay up to 13 days on average

    Length of stay in hospital

  5. Hours admitted in post operative care unit (PACU)

    Time frame: On average up to 14 hours

    Length of stay in PACU

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University College of Southeast Norway

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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