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Randomized Controlled Trial
. 2018 Sep 8;18(1):126.
doi: 10.1186/s12871-018-0582-9.

Maintaining intraoperative normothermia reduces blood loss in patients undergoing major operations: a pilot randomized controlled clinical trial

Affiliations
Randomized Controlled Trial

Maintaining intraoperative normothermia reduces blood loss in patients undergoing major operations: a pilot randomized controlled clinical trial

Jie Yi et al. BMC Anesthesiol. .

Abstract

Background: Inadvertent intraoperative hypothermia (core temperature < 36 °C) is a common but preventable adverse event. This study aimed to determine whether active intraoperative warming reduced bleeding in patients undergoing major operations: open thoracic surgery and hip replacement surgery.

Methods/design: The study was a pilot, prospective, parallel two-arm randomized controlled trial. Eligible patients were randomly allocated to two groups: passive warming (PW), with application of a cotton blanket (thermal insulation), or active warming (AW), with a forced-air warming system. The primary endpoint was intraoperative blood loss, and secondary endpoints were surgical-site infection, cardiovascular events, and length of stay in the post-anesthesia care unit, intensive care unit, and hospital.

Results: Sixty-two patients were enrolled. Forced-air active warming maintained intraoperative normothermia in all AW subjects, whereas intraoperative hypothermia occurred in 21/32 (71.8%) of PW patients (p = 0.000). The volume of blood loss was more in the PW group (682 ± 426 ml) than in the AW group (464 ± 324 ml) (p < 0.021), and the perioperative hemoglobin value declined more in the PW group (28.6 ± 17.5 g/L) than in the AW group (21.0 ± 9.9 g/L) (p = 0.045). However, there were no difference in other clinical outcomes between two groups.

Conclusion: Intraoperative active warming is associated with less blood loss than passive warming in open thoracic and hip replacement operations in this pilot study.

Trial registration: This trial was registered with Clinicaltrials.gov (Identifier: NCT02214524 ) on 27 August 2014.

Keywords: Active forced warming; Inadvertent intraoperative hypothermia; Intraoperative bleeding; Major surgery; Passive warming.

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Conflict of interest statement

Ethics approval and consent to participate

This study protocol was approved by Institute Review Boards (IRB) of Peking Union Medical College Hospital (PUMCH) in Beijing, China. Written informed consent was obtained from patients or surrogates prior to screening.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow Chart of Study. A total of 64 patients were screened. Two patients were excluded; 62 were enrolled and randomly allocated to two groups: passive warming (PW) and active warming (AW). Data analysis was based on the intent-to-treat (ITT) population

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