- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07065812
- Ursprunglig rättegång
Team-kännedom och perioperativa resultat vid icke-gardialkirurgi
Effekterna av teamförkänning på kirurgiska resultat och patientsäkerhet vid icke-hjärtkirurgi
Målet med denna retrospektiva observationsstudie är att kvantifiera effekterna av teamsamarbete om arbetseffektivitet i operationssalen och patientsäkerhetsresultaten i icke-hjärtkirurgiska team. Huvudsyftet är att svara:
Hur påverkar teamsamarbetet arbetseffektivitet i operationssalen och patientsäkerhetsresultaten under/efter operationen? Uppgifterna kommer att erhållas från sjukhusets elektroniska informationssystem för medicinsk post, deltagarna avslutade redan alla planerade operationer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210009
- Zhongda Hospital, Southeast University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inkluderingskriterier:
- Alla valfria operationer för vuxna (ålder ≥18 år)
Uteslutningskriterier:
- Operationer där patientdemografi (ålder, kön), ASA -klass, procedurdetaljer och positionsdata var ouppnåliga
- Hjärtkirurgiska ingrepp (med ett fast kirurgiskt team)
- Operationer under icke-intuberad allmän anestesi eller intravenös anestesi (främst diagnostiska procedurer som inte kräver nära tvärvetenskapligt samarbete)
- Kirurgiska fall med saknade data om pre-anestesi-beredningstid, anestesiinduktionstid och kirurgisk procedurvaraktighet
- Kirurgiska fall med saknade uppgifter om teammedlemmarnas år av erfarenhet och könsinformation.
- Kirurgiska fall med saknade uppgifter om stora komplikationer inom och efter operationen och andra säkerhetsrelaterade resultatmått
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Non-Cardiac Surgery Cohort
Adult patients undergoing elective non-cardiac surgery.
Operating room team familiarity will be quantified using the Intraoperative Familiarity Score (IFS), and its association with perioperative outcomes will be evaluated.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Operating Room Team Efficiency
Tidsram: During the index surgical procedure, assessed up to 24 hours
|
Operating room team efficiency is assessed by three workflow time intervals:
All time intervals are measured in minutes based on timestamps recorded in the anesthesia information management system. |
During the index surgical procedure, assessed up to 24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Estimated Intraoperative Blood Loss
Tidsram: During the index surgical procedure, assessed up to 24 hours
|
Total estimated blood loss during surgery, recorded in milliliters (mL) from anesthesia and surgical records.
|
During the index surgical procedure, assessed up to 24 hours
|
|
Duration of Post-Anesthesia Care Unit (PACU) Stay
Tidsram: From transfer from the operating room to the PACU until transfer from the PACU to the ward after the index surgery, assessed up to 12 hours
|
The duration of PACU stay, defined as the time interval from admission to discharge from the post-anesthesia care unit, recorded in minutes.
|
From transfer from the operating room to the PACU until transfer from the PACU to the ward after the index surgery, assessed up to 12 hours
|
|
Postoperative ICU Admission
Tidsram: From completion of the index surgical procedure until hospital discharge, assessed up to 90 days
|
Whether the participant was admitted to the intensive care unit after the index surgery (yes/no), including direct transfer from the operating room to the ICU without PACU recovery, identified from postoperative medical records.
|
From completion of the index surgical procedure until hospital discharge, assessed up to 90 days
|
|
Duration of ICU Stay
Tidsram: From postoperative ICU admission until ICU discharge or transfer to the ward during the index hospitalization (recorded as 0 days if no ICU admission), assessed up to 90 days
|
Length of postoperative ICU stay in days.
Participants not admitted to the ICU are recorded as 0 days; for those admitted (including direct transfer from the operating room to the ICU), duration is measured from ICU admission until ICU discharge or transfer to the ward.
|
From postoperative ICU admission until ICU discharge or transfer to the ward during the index hospitalization (recorded as 0 days if no ICU admission), assessed up to 90 days
|
|
Unplanned Secondary Surgery Within 31 Days After Surgery
Tidsram: From the day of the index surgical procedure, assessed up to 31 days
|
Occurrence of an unplanned secondary surgical procedure within 31 days after the index surgery, identified from hospital surgical records.
|
From the day of the index surgical procedure, assessed up to 31 days
|
|
In-Hospital Mortality
Tidsram: From the day of the index surgical procedure until hospital discharge, assessed up to 90 days
|
Death occurring during the index hospitalization after surgery, identified from hospital medical records.
|
From the day of the index surgical procedure until hospital discharge, assessed up to 90 days
|
|
Unplanned Hospital Readmission Within 31 Days After Surgery
Tidsram: From the day of the index surgical procedure, assessed up to 31 days
|
Occurrence of an unplanned hospital readmission within 31 days after the index surgical procedure, defined as an unexpected inpatient admission after discharge from the index hospitalization and identified from hospital medical records.
|
From the day of the index surgical procedure, assessed up to 31 days
|
|
Length of Hospital Stay
Tidsram: From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
Total duration of hospitalization, measured in days, from hospital admission to discharge after the index surgical procedure.
|
From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
|
Total Hospitalization Cost
Tidsram: From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
Total hospitalization expenses associated with the index surgical procedure, recorded in Chinese Yuan (CNY) based on hospital billing records.
|
From hospital admission until hospital discharge for the index surgical procedure, assessed up to 90 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025ZDSYLL172-P01
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