Anesthesia; Adverse EffectPACUNCT06396000
Factors Analysis Related to Prolonged Stay in the Pediatric Post-Anesthesia Care Unit(PACU)
An observational study of Anesthesia; Adverse Effect, run by Saiqiang Guo.
Trial summary
The purpose of this study is to determine which factors contribute to prolonged stay of children in the PACU. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anesthesia; Adverse Effect
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2024to 31 Mar 2025
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Pediatric patient entering the Pediatric Post-Anesthesia Care.
Who may be able to join
- Children aged 0-18 years old; Child entering the Pediatric Post-Anesthesia Care.
- Emergency surgery; Pediatric patients with incomplete medical history; Pediatric patients requiring postoperative ICU care; Pediatric patients with preoperative altered consciousness; Neurological disorders; Severe liver, kidney, lung, and heart diseases.
Who cannot join
None listed.
About this study
Official title: Prolonged Stay in the Pediatric PACU
The purpose of this study is to determine which factors contribute to prolonged stay of children in the PACU.
Read the detailed description
Studying the factors associated with prolonged stay of children in the PACU is of great significance to the medical team, as it can improve the quality and speed of anesthesia recovery, not only in line with the concept of accelerated rehabilitation surgery, but also through intervention and optimization of specific factors to improve the efficiency of children's postoperative discharge from the PACU, reduce the incidence of complications, lower medical costs, and increase patient and family satisfaction. Therefore, this study aims to explore the factors associated with prolonged stay of children in the PACU through retrospective analysis.
- Conditions
- Anesthesia; Adverse Effect
- Keywords
- Post-anesthesia care unit, Risk factors, Pediatrics
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Plan Selection
Anesthesia options include general anesthesia, combined anesthesia, pure intravenous anesthesia, and nerve block anesthesia.
Measured: Day 1
Pain Score
Evaluate pain using the Visual Analog Scale (VAS): 0 points: no pain; 1-3 points: mild pain; 4-6 points: moderate pain; 7-10 points: severe pain.
Measured: Day 1
Complications in PACU
Nausea, vomiting, chills, pain, agitation
Measured: Day 1
American Society of Anesthesiologists（ASA）
ASA I: Patients in good health, without systemic disease. ASA II: Patients with mild systemic disease, not significantly limiting daily activity.
ASA III: Patients with severe systemic disease, with definite functional limitation.
ASA IV: Patients with severe systemic disease that is a constant threat to life.
ASA V: Moribund patients who are not expected to survive without the operation. ASA VI: Brain-dead patients whose organs are being removed for donation.
Measured: Day 1
The medication usage in PACU
Morphine, Propofol, Ketorolac, Fentanyl
Measured: Day 1
Secondary outcomes (1)
The use of PCA（Patient-Controlled Analgesia）in PACU
PCA usage statistics，yes or no
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start31 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saiqiang Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Saiqiang Guo, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396000
- Sponsor's protocol ID
- FARPSPP
- Acronym
- PACU
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Stay in the Pediatric PACU
- ClinicalTrials.gov ID
- NCT06396000
- Acronym / sponsor ID
- PACU / FARPSPP
- Conditions
- Anesthesia; Adverse Effect
- Keywords
- Post-anesthesia care unit, Risk factors, Pediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Saiqiang GuoUniversity, hospital or other
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 May 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.
The purpose of this study is to determine which factors contribute to prolonged stay of children in the PACU.
Detailed description
Studying the factors associated with prolonged stay of children in the PACU is of great significance to the medical team, as it can improve the quality and speed of anesthesia recovery, not only in line with the concept of accelerated rehabilitation surgery, but also through intervention and optimization of specific factors to improve the efficiency of children's postoperative discharge from the PACU, reduce the incidence of complications, lower medical costs, and increase patient and family satisfaction. Therefore, this study aims to explore the factors associated with prolonged stay of children in the PACU through retrospective analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patient entering the Pediatric Post-Anesthesia Care.
Key inclusion criteria (2 listed)
- Children aged 0-18 years old; Child entering the Pediatric Post-Anesthesia Care.
- Emergency surgery; Pediatric patients with incomplete medical history; Pediatric patients requiring postoperative ICU care; Pediatric patients with preoperative altered consciousness; Neurological disorders; Severe liver, kidney, lung, and heart diseases.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anesthesia Plan Selection
Time frame: Day 1
Anesthesia options include general anesthesia, combined anesthesia, pure intravenous anesthesia, and nerve block anesthesia.
Pain Score
Time frame: Day 1
Evaluate pain using the Visual Analog Scale (VAS): 0 points: no pain; 1-3 points: mild pain; 4-6 points: moderate pain; 7-10 points: severe pain.
Complications in PACU
Time frame: Day 1
Nausea, vomiting, chills, pain, agitation
American Society of Anesthesiologists（ASA）
Time frame: Day 1
ASA I: Patients in good health, without systemic disease. ASA II: Patients with mild systemic disease, not significantly limiting daily activity. ASA III: Patients with severe systemic disease, with definite functional limitation. ASA IV: Patients with severe systemic disease that is a constant threat to life. ASA V: Moribund patients who are not expected to survive without the operation. ASA VI: Brain-dead patients whose organs are being removed for donation.
The medication usage in PACU
Time frame: Day 1
Morphine, Propofol, Ketorolac, Fentanyl
1 secondary outcome
The use of PCA（Patient-Controlled Analgesia）in PACU
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Adverse Effect, run by Saiqiang Guo.
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Anesthesia Plan Selection (time frame: Day 1). The study lists 5 primary outcomes in all. 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 3 May 2024.