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Perioperative Active Warming Strategies in Children: A multicenter,prospective, randomized controlled trial

Perioperative Active Warming Strategies in Children: A multicenter,prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062168
Enrollment
Unknown
Registered
2022-07-26
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Inadvertent Perioperative Hypothermia

Interventions

Active warming strategies group (Group A):Perform perioperative active warming strategies for children
Control group (Group C):Perform perioperative routine passive warming measure for children

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Pediatric patients =1 years old and = 12 years old, no gender limitation; 2.Scheduled for elective surgery under general anesthesia or general anesthesia combined with other anesthesia methods; 3.American Society of Anesthesiologists physical status of I–II; 4.Estimated operation time is > 40 min; 5.According with the normal range of WHO Child Growth Standards.

Exclusion criteria

Exclusion criteria: 1.Abnormal body temperature caused by diseases or medicines before operation; 2.The elective surgery requires controlled hypothermia; 3.Children with the definite history of cardiac insufficiency or congenital heart disease; 4.Children with the definite history of metabolic diseases, such as thyroid dysfunction, diabetes; 5.The changes in laboratory examination of blood routine, blood biochemistry, blood clotting exceed 1.5 times the normal value; 6.Tracheal tube is expected to be retained after operation; 7.Postoperative thermoregulation is expected to be affected; 8.Unwilling to participate in this trial or participate in other clinical trial.

Design outcomes

Primary

MeasureTime frame
Perioperative cumulative hypothermia effect value (S ?Ti × ?ti, i=1, ..., n);

Secondary

MeasureTime frame
Cumulative hypothermia effect value (S ?Ti × ?ti, i=1, ..., n) in preoperative waiting room, operating room, and PACU;Difference value between intraoperative core temperature and axillary temperature;Results of arterial blood gas analysis in anesthesia recovery period, including pH, lactic acid, and hemoglobin values;Shivering score, Cornell assessment of pediatric delirium score, and thermal comfort score in anesthesia recovery period;The morbidity of major complications during postoperative hospitalization;The incidence of incision infection during hospitalization;Body temperature in the morning of the first day after operation;Length of stay and expenses;All-cause mortality during 30 days after operation;

Countries

China

Contacts

Public ContactXu Jin

Beijing Tiantan Hospital, Capital Medical University

xiehe2000@163.com13693336261

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026