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Effect of patient insulation technology based on real-time temperature closed-loop feedback on perioperative complications and rehabilitation prognosis of elderly patients with fragile fracture

Effect of patient insulation technology based on real-time temperature closed-loop feedback on perioperative complications and rehabilitation prognosis of elderly patients with fragile fracture

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083027
Enrollment
Unknown
Registered
2024-04-15
Start date
2024-04-15
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Senile fragility fracture

Interventions

Test group:Closed loop feedback based on real-time body temperature
Control group:Conventional temperature measurement and manual inflatable insulation

Sponsors

Xi’an Honghui Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: a) The results of X-ray or CT orthopedic examination suggested femoral intertrochanteric fracture, and traction bed was used for closed reduction and internal fixation of fracture; b) Older people aged 60-80 years, regardless of gender; c) Signed informed consent;

Exclusion criteria

Exclusion criteria: a) Have a history of severe skin allergy, especially to silica gel or medical plastic; b) Suffering from cerebral hemorrhage and other chronic diseases that affect the thermoregulatory function; c) Patients with severe hypothermia before operation (the highest temperature in the first day before operation does not exceed 35.5 ?); d) Having malignant tumor and family history of hematological disease; e) Those who are mentally abnormal and do not cooperate;

Design outcomes

Primary

MeasureTime frame
30 day postoperative mortality;The incidence of postoperative deep vein thrombosis and lower extremity edema;Incidence of postoperative pulmonary infection;Incidence of surgical incision infection;Heart failure assessment;Postoperative prothrombin time, postoperative hemoglobin;Intraoperative blood loss;Mini Mental State Examination (MMSE);Postoperative plasma NT-proBNP levels;

Secondary

MeasureTime frame
Incidence of intraoperative hypothermia;Incidence of hypothermia 24 hours after operation;Proportion of body temperature below 36 ? during operation;Proportion of body temperature below 36 ? 24 hours after operation;Safety of thermal insulation system: incidence of adverse events such as skin allergy and pressure ulcer;Postoperative hospital stay and total cost from postoperative to discharge;

Countries

China

Contacts

Public ContactWang Fang

Xi’an Honghui Hospital

2477557343@qq.com+86 139 9123 7605

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026