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A Pilot Study of the Efficacy and Safety of A "Wireless Monitoring-Intelligent Warming" Closed-Loop System for Intraoperative Temperature Control

A Pilot Study of the Efficacy and Safety of A "Wireless Monitoring-Intelligent Warming" Closed-Loop System for Intraoperative Temperature Control

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077415
Enrollment
Unknown
Registered
2023-11-08
Start date
2023-11-08
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

intraoperative hypothermia

Interventions

experimental group:Patients will be warmed by an Eternal H680B Series medical heating blanket during the surgery, with the expected range of body temperature set to 36.2?-36.8?, and the target tempera
control group:Patients will be warmed by a 3M Bair Hugger Series air-forced blanket during the surgery. The warming system will be turned on and set to 43? by a medical personnel when the patient’s bo

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 65 years and older. 2. Patients undergoing elective abdominal surgery under general anesthesia with an estimated operative time more than 2 hours. 3. The informed consent is signed.

Exclusion criteria

Exclusion criteria: 1. Patients who require intravenous infusion of both upper limbs. 2. Patients with a history of severe skin allergy, especially who are allergic to silica gel or medical plastics. 3. Patients with a special surgical position which makes the warming blanket or warming pad unavailable. 4. Patients proposed to transfer with tracheal catheter into ICU after surgery.

Design outcomes

Primary

MeasureTime frame
Time proportion of normothermia (36-37?) throughout the surgery;

Secondary

MeasureTime frame
incidence of intraoperative hypothermia;time poportion of body temperature < 36? during the surgery;time poportion of body temperature < 36? during the PACU stay;time proportion of body temperature < 36? during the perioperative period (including the anesthesia and surgery period and the PACU stay);incidence of hypothermia when entering the PACU;incidence of postoperative shivering;the alarm frequency of the warming device;incidence of real-time temperature higer than 38?;incidence of real-time body temperature lower than 35?;incidence of adverse events;emergence time;time to extubation;the Riker sedation agitation scale score during resuscitation;satisfaction scores of patients for the intraoperative temperature management;satisfaction scores of anesthesiologists for the intraoperative temperature management;satisfaction scores of nurses in the PACU for the intraoperative temperature management;

Countries

China

Contacts

Public ContactYuyi Zhao

West China Hospital of Sichuan University

343490507@qq.com+86 189 8060 6837

Outcome results

None listed

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