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

NCT06568809 | Completed

• 1 other identifier: SAHoWMU-CR2024-03-216
• Study Type: observational
• Target: 3,053
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fever

Keywords

Fever; SARS-CoV-2; Hypoxemia; Children

Outcome Measures

Primary Outcomes (1)

• Pulse oxygen saturation

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

  intubation, extubation and operation

Study Arms (2)

0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8 weeks

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. 1. Before operation: ① Ask the children about the history of upper respiratory tract infection complicated with fever, and record the symptoms of upper respiratory tract infection. ② The symptoms of upper respiratory tract infection were collected on the day of operation. ③ Record the patient's age, sex, height, weight and ASA grade. ④ The preoperative chest X-ray imaging examination was collected. 2. During the operation: * Record the average arterial pressure and heart rate before and after entering the room, intubation, extubation and operation room. ② Record the lowest value of oxygen saturation of hypoxemia during intubation and extubation. ③ Record the treatment process when PRAEs appear. ④ Record all anesthetic dosage. ⑤ Record the total operation time.

Other: Time interval between recovery of body temperature and operation

≥3 month(control group)

The time between body temperature recovery and surgery was collected as categorical factor and was scheduled to be analyzed in the following categories≥ 3 months (control group). 1. Before operation: ① Ask the children about the history of upper respiratory tract infection complicated with fever, and record the symptoms of upper respiratory tract infection. ② The symptoms of upper respiratory tract infection were collected on the day of operation. ③ Record the patient's age, sex, height, weight and ASA grade. ④ The preoperative chest X-ray imaging examination was collected. 2. During the operation: * Record the average arterial pressure and heart rate before and after entering the room, intubation, extubation and operation room. ② Record the lowest value of oxygen saturation of hypoxemia during intubation and extubation. ③ Record the treatment process when PRAEs appear. ④ Record all anesthetic dosage. ⑤ Record the total operation time.

Other: Time interval between recovery of body temperature and operation

Interventions

Time interval between recovery of body temperature and operation OTHER

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).

0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8 weeks; ≥3 month(control group)

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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. Body temperatures over 37.5 degrees Celsius was considered as fever. The patient's guardian provided the recovery date of the child's 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).

You may qualify if:

• \) 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Fever; Hypoxia

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Lu Yi, physician

  The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician-in-charge

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: March 11, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: August 23, 2024

Record last verified: 2023-03

Locations

CN (1)