Clinical Trial: National Epidemiologic Survey on the Incidence of Perioperative Hypothermia
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
Official Title: National Epidemiologic Survey on the Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in China
Brief Summary:
Study Objective:
- to project the incidence of perioperative hypothermia in patients with elective surgery under general anesthesia in China
- to determine the risk factors associated with perioperative hypothermia.
- to explore the patient outcome of hypothermia such as cardiovascular events, wound infection,hospital stay and so on.
Study Design: The present study is a cross-sectional study with 30-day follow-up period.
Detailed Summary:
This survey was anticipated to enroll 2208 patients with elective surgery under general anesthesia from 28 hospitals or so in China. After obtaining approval from the Ethical Committee related to research involving human subjects,the investigators will enroll the patients according to the inclusion and exclusion criterion. The tympanic temperature will be monitored at the following time points respectively: Arriving at waiting area, entering the OR room, 5 min before and after anesthesia induction, every 15 min during the operation, after 2h the tympanic temperature will be monitored at every 30 min, Tympanic temperature will also be taken when the surgery complete and when patients arrived at PACU. Other information will also be collected including the type and dosage of anesthesia drug,duration of surgery and anesthesia, patient warming method，operation room temperature, the amount of the infusion of intravenous fluids and blood and their warming techniques during the whole operation procedure. The postoperative follow-up will be conducted and recorded within 30 days after operation(for implantation surgery, the follow-up will be conducted within 90 days postoperatively ) which includes ICU stays, hospital stays, wound infection, new cardiovascular events.etc.
The contract research organization will be delegated to do an on site monitor once a month (online monitor once a week) for each hospital participate the survey during the recruitment and perform the source data validation at the same time to review the related medical records,source data and the case report forms, etc.to ensure the data accuracy and completeness.
Data management will be conducted through the whole survey procedure. In order to guarantee the validation of the data, two data managing staffs will input and verify the data independently.
Current Primary Outcome: the incidence of perioperative hypothermia [ Time Frame: from patients entered operating room to transfering to post anesthesia care units ]
Original Primary Outcome: Same as current
Current Secondary Outcome: record the postoperative adverse events [ Time Frame: From the day after operation to 30 days thereafter ]
Original Secondary Outcome: Same as current
Information By: Peking Union Medical College Hospital
Dates:
Date Received: August 6, 2014
Date Started: September 2014
Date Completion: December 2015
Last Updated: August 6, 2014
Last Verified: August 2014
