Inadvertent Perioperative Hypothermia, Preoperative Anxiety Experienced by the Patient
Conditions
Keywords
Patient warming, Active warming, Forced Air Warming, Warming blanket
Brief summary
This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively. A non-inferiority, prospective, open-labelled, randomized, parallel investigation. Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia. The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups. A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.
Interventions
DEVICEActive self warming blanket
BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.
Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF) * Male and female subjects aged 18 years and over * Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes * Scheduled surgery must be performed entirely under general anaesthesia * The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area * The subject must have an oral temperature measurement of at least 36.0°C when first measured in the preoperative setting * The subject's scheduled surgical procedure must allow time to be warmed with a fully activated BARRIER® EasyWarm at least 30 minutes prior to induction of general anaesthesia
Exclusion criteria
* Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater * Known Diabetes with an HbA1c of more than 6 % * Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of: 1. The subject's normal temperature regulation or 2. Perception of external temperature or 3. Subcutaneous lipoatrophy * Current use of concomitant medications that present relevant risk to/of: 1. The subject's normal temperature regulation or 2. Perception of external temperature or 3. Subcutaneous lipoatrophy * Epidural/Spinal anaesthesia * An oral temperature measurement ≥ 37.5° * Contraindications to the oesophagus temperature probe and oral thermometer * Presence of skin and soft tissue disorders in areas covered directly by the device in the two treatment groups (e.g. pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat) * Pregnancy * Severe non-compliance to protocol as judged by the investigator and/or Mölnlycke Health Care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference in Core Body Temperature in the Two Treatment Groups. | Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours. | Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op. |
Countries
Germany, Norway, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Self-warming Blanket Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase
Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron. | 28 |
| Forced Air Warming Device Active warming with forced air warming (FAW) during the intraoperative phase.
Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection. | 27 |
| Total | 55 |
Baseline characteristics
| Characteristic | Active Self-warming Blanket | Forced Air Warming Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 27 Participants | 55 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 13.2 | 50 years STANDARD_DEVIATION 14.44 | 49.5 years STANDARD_DEVIATION 13.82 |
| Region of Enrollment Germany | 15 participants | 14 participants | 29 participants |
| Region of Enrollment Norway | 7 participants | 7 participants | 14 participants |
| Region of Enrollment United Kingdom | 4 participants | 6 participants | 10 participants |
| Sex: Female, Male Female | 27 Participants | 24 Participants | 51 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 28 | 1 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 |
Outcome results
Primary
The Difference in Core Body Temperature in the Two Treatment Groups.
Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.
Time frame: Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Self-warming Blanket | The Difference in Core Body Temperature in the Two Treatment Groups. | 36.28 degree celsius | Standard Deviation 0.3 |
| Forced Air Warming Device | The Difference in Core Body Temperature in the Two Treatment Groups. | 36.25 degree celsius | Standard Deviation 0.33 |