Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes

The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.

Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:

* Increased comfort in the pre-operative period by being warmer * Decreased incidence of mild hypothermia * Possible decreased incidence of transfusion with less bleeding * Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU) * Possible shorter stay in the PACU and overall Length of Stay (LOS) * Possible decreased risk for surgical site infection

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Key information

Conditions

Hypothermia Anxiety Disorders Body Temperature Changes Hemorrhage Infections Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital

Vancouver, British Columbia, V3L 3W7, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Elective or "urgent" surgery under general anesthesia
≥19 years but ≤85 years of age
Able to provide informed consent.

Exclusion criteria

Refusal of Informed consent
Metabolic derangement/drug therapy already affecting thermal homeostasis
Preexisting hypothermia (<35.5 degreeC) or hyperthermia (>37.5 degreeC) (oral)
Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
Emergency (category 1a) Surgery
Patients undergoing exclusively spinal or epidural anesthesia
Patients receiving aortic cross-clamping
Patients receiving transdermal medications

Treatment and study plan

Bair Paws Patient Adjustable Warming System

Device

Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.

Other names: Bair Paws Flex Gown

Primary outcomes

Duration of hypothermia

Time frame: Up to 12 hours, until PACU discharge

The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

Registry information

Official study title

Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 30, 2014
Registry last updated: Oct 2, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed