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临床试验/NCT06568809
NCT06568809已完成不适用

Timing of Surgery in Pediatric Patients Following Fever Recovery: a Prospective Cohort Study

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 3,053 人开始时间: 2023年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,053
试验地点
1
主要终点
Pulse oxygen saturation

研究概览

简要总结

Objectives: The timing of fever recovery may affect the risk of intra-operative hypoxemia in children undergoing elective surgery after SARS-CoV-2 infection. This study aims to determine the optimal timing for surgery by analyzing the occurrence of intra-operative hypoxemia in pediatric patients after they have recovered from a fever.

Methods: This prospective cohort study included 3053 children who had been infected with SARS-CoV-2 and developed fever, and scheduled to a surgery during March 2023 to August 2023, children with temperature recovery time ≥3 month were compared to children with temperature recovery time 0-8weeks. The primary outcome was measured as the incidence of intra-operative hypoxemia in SARS-CoV-2 infected children after their body temperature returned to normal. Logistic regression models were used to calculate the adjusted incidence of hypoxemia rate sratified by time (0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8 weeks; ≥3 month) from body temperature recovery to the day of surgery.

详细描述

This prospective cohort study included 3053 pediatric patients who had been infected with SARS-CoV-2 and developed fever, and scheduled to a surgery during March 2023 to August 2023.On the day of operation, the anesthesiologist in the children's operating room conducted a preoperative evaluation. Upon confirming that general anesthesia was appropriate, they proceeded to sign the informed consent for anesthesia. Three anesthesiologists were assigned to the research group and conducted a second preoperative visit to the children and their guardians in a separate room.

Body temperatures over 37.5 degrees Celsius was considered as fever. The time between body temperature recovery and surgery was collected as categorical factor and was scheduled to be analyzed in the following categories: 0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8 weeks; And ≥ 3 months (control group). After entering the operating room, the children were routinely monitored (pulse oxygen saturation-SpO2, blood pressure and electrocardiogram). The anesthesia method and drug selection were decided by the anesthesiologist in the operating room. The following data were collected and recorded: age, height, weight and ASA classification; The preoperative medication and the perioperative use of narcotic drugs ; The induction technique; The primary airway device; The lowest value of SpO2 when the child entered the operating room, was intubated and was extubated; PRAEs (such as cough, wheezing, laryngeal spasm and bronchial spasm) occurred during operation; The treatment processwhen PRAEs occured; The total duration of operation. The primary outcome was the incidence of intra-operative hypoxemia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients aged 1 to 18 years old; 2) American Society of Anesthesiologists physical status (ASA) Ⅰ or Ⅱ; 3) Undergoing selective tonsillectomy, nasal and paranasal sinus surgery, inguinal hernia repair, circumcision, internal fixation removal and other elective or daytime operations in otolaryngology, general surgery or orthopedics.

排除标准

  • the weight is either less than or more than 15% of standard weight [standard weight (kg) = height (cm) -100]; 2) body mass index (BMI) < 13.5 kg/m2 or > 31 kg/m2; 3) presence of asthma or airway hyperresponsiveness, neuromuscular systemic disease or cachexia, or difficult airway; 4) abnormal surgical anesthesia recovery history; 5) operation duration > 2 hours; 6) participants in any drug clinical trial within 30 days before the study; 7) absence of a definite date of fever recovery and other conditions deemed unsuitable for inclusion by the researchers.

结局指标

主要结局

Pulse oxygen saturation

时间窗: intubation, extubation and operation

Record the lowest oxygen saturation of hypoxemia during intubation, extubation and operation.

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lu Yi

physician-in-charge

Second Affiliated Hospital of Wenzhou Medical University

研究点 (1)

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