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The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. Subsequently, they will be treated with either one, two or four heating blankets, and analyses will be performed to investigate whether we are able to find a difference between the three groups.
The aim of this pilot study is to evaluate if there is a dose-response relationship between the use of active external rewarming devices and core temperature rewarming rate from simulated accidental hypothermia. Volunteer research participants will be cooled in a field laboratory, and they will recieve medications to inhibit shivering, enabeling a drop in core temperature. All participants will be monitored extensively using a trans-nasal esophageal temperature probe, ECG, SpO2, Blood pressure, skin temperature and with subjective scores. After the cooling phase, the participants will be treated with either one, two or four heating blankets assigned in a randomized order, and analyses will be performed to investigate whether we are able to find a difference between the three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One active external rewarming device | Experimental | Participants in this group will recieve one active external rewarming device |
|
| Two active external rewarming devices | Experimental | Participants in this group will recieve two active external rewarming devices |
|
| Four active external rewarming devices | Experimental | Participants in this group will recieve four active external rewarming devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active external rewarming device | Device | Electrical heating blanket |
|
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal temperature rewarming rate | Developement of esophageal temperature during the rewarming phase after cooling. Participants will be shiver-inhibited in this phase of the trial | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øyvind Thomassen, MD, PhD | Haukeland University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Bergen | 5009 | Norway |
Risk of identifiable data due to a low number of participants
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| Active external rewarming device 2 | Device | Electrical heating blanket |
|
| Active external rewarming device 3 | Device | Electric heating blanket |
|
| Active external rewarming device 4 | Device | Electric heating blanket |
|
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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