Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568809
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Timing of Surgery in Pediatric Patients Following Fever Recovery a Prospective Cohort Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Timing of Surgery in Pediatric Patients Following Fever Recovery a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 2023On the day of operation the anesthesiologist in the childrens 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 375 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
Body temperatures over 375 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None