Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-31 @ 8:13 AM
Study NCT ID:
NCT02177903
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
Sponsor:
Solventum US LLC
Organization:
Study Overview
Official Title:
Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: