FeverNCT06568809
Timing of Surgery in Pediatric Patients Following Fever Recovery: a Prospective Cohort Study
An observational study of Fever, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Fever
- What is being tested?
- Time interval between recovery of body temperature and operation
- How many people
- 3,053 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2023to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 1) 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.
Who cannot join
- 1) 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
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.
Read the 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 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.
- Conditions
- Fever
- Being tested
- Time interval between recovery of body temperature and operation
- Keywords
- Fever; SARS-CoV-2; Hypoxemia; Children
- Medical subject headings
- Fever, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time interval between recovery of body temperature and operationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Time interval between recovery of body temperature and operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse oxygen saturation
Record the lowest oxygen saturation of hypoxemia during intubation, extubation and operation.
Measured: intubation, extubation and operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start11 Mar 2023
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,053 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Yi, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Lu Yi, physician, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568809
- Sponsor's protocol ID
- SAHoWMU-CR2024-03-216
- Status last verified
- Mar 2023
- First submitted
- 21 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Surgery in Pediatric Patients Following Fever Recovery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06568809
- Acronym / sponsor ID
- SAHoWMU-CR2024-03-216
- Conditions
- Fever
- Keywords
- Fever; SARS-CoV-2; Hypoxemia; Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,053 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 11 Mar 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8 weeks | – | Other: Time interval between recovery of body temperature and operationThe 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. |
| ≥3 month(control group) | – | Other: Time interval between recovery of body temperature and operationThe 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (1 listed)
- 1) 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.
Key exclusion criteria (1 listed)
- 1) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time interval between recovery of body temperature and operationThe 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). | Other | 0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8 weeks, ≥3 month(control group) |
Primary outcome
Pulse oxygen saturation
Time frame: intubation, extubation and operation
Record the lowest oxygen saturation of hypoxemia during intubation, extubation and operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Yi, physician principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oxygen saturation (time frame: intubation, extubation and operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.